<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03256578</url>
  </required_header>
  <id_info>
    <org_study_id>826695</org_study_id>
    <secondary_id>NTR4104</secondary_id>
    <nct_id>NCT03256578</nct_id>
  </id_info>
  <brief_title>Monitoring Neonatal Resuscitation Trial</brief_title>
  <acronym>MONITOR</acronym>
  <official_title>A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Women's Hospital in Melbourne, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal &amp; Children's University Hospital, Valencia, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vittore Buzzi Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized trial to determine if a visible respiratory function monitor (RFM)&#xD;
      displaying realtime measurements of delivered inflations improves clinical providers ability&#xD;
      to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in&#xD;
      preterm infants after birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can&#xD;
      guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life&#xD;
      Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure&#xD;
      and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New&#xD;
      Life Box uses a small variable orifice anemometer to measure gas flow in and out of a&#xD;
      face-mask or endotracheal tube. This signal is automatically integrated to provide inspired&#xD;
      (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or&#xD;
      endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from&#xD;
      the infant is seen during a positive pressure inflation. The RFM can also calculate and&#xD;
      measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all&#xD;
      ventilation pressures. Using customized software heart rate, oxygen saturation and expired&#xD;
      carbon dioxide can be integrated into the RFM.&#xD;
&#xD;
      The NewLife Box monitor presents graphical information for pressure, flow, and volume. In&#xD;
      addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti,&#xD;
      Vte), flow, respiratory rate and percent leak. The monitor integrates and displays&#xD;
      physiologic data streaming from the patient (heart rate and oxygen saturation) as well as&#xD;
      FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled,&#xD;
      the monitor can incorporate video captured from an external camera. The video serves as a&#xD;
      helpful aid in the interpretation of the events during the RFM waveform recordings.&#xD;
&#xD;
      The use of an RFM in the DR has the potential to improve neonatal respiratory support and&#xD;
      reduce lung injury.&#xD;
&#xD;
      The primary objective of this study is to test the hypothesis that observing the data and&#xD;
      waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks&#xD;
      gestation) after birth will increase the proportion of inflations performed with a predefined&#xD;
      VTe &quot;safe range&quot; of 4 - 8 mls/kg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The waveform data and videos captured during the study intervention will be centralized to Leiden University Medical Center. The team at Leiden University Medical Center assessing the outcomes will be will be blinded to the randomization allocation of the infant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg</measure>
    <time_frame>the first 15 minutes of resuscitation</time_frame>
    <description>To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe &quot;safe range&quot; of 4 - 8 mls/kg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life</measure>
    <time_frame>approximately first 5 minutes of life</time_frame>
    <description>Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate in the First 10 Minutes of Life</measure>
    <time_frame>between 3 and 10 minutes of life</time_frame>
    <description>Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Mask Leak During PPV Ventilation</measure>
    <time_frame>approximately first 15 minutes of resuscitation</time_frame>
    <description>Percentage of time with significant mask leak (defined as &gt; 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of PPV Inflations With Airway Obstruction</measure>
    <time_frame>approximately first 15 minutes of resuscitation</time_frame>
    <description>Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte &lt;1 mL/kg, with minimal mask leak (&lt;25%) during an inflation and flattening of the flow waves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of PPV Inflations With Inadequate Tidal Volume</measure>
    <time_frame>approximately first 15 minutes of resuscitation</time_frame>
    <description>Percentage of PPV inflations with inadequate tidal volume defined as Vte &lt;4 ml/kg in the first 15 minutes of resuscitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life</measure>
    <time_frame>Between 3 and 10 minutes of life</time_frame>
    <description>Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life</measure>
    <time_frame>between 3 and 10 minutes of life</time_frame>
    <description>Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life</measure>
    <time_frame>approximately first 10 minutes of life</time_frame>
    <description>Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving Endotracheal Intubation in the Delivery Room</measure>
    <time_frame>from time of birth to admission to NICU</time_frame>
    <description>Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Inotropes for Circulatory Support</measure>
    <time_frame>within the first 3 days after birth</time_frame>
    <description>Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Pneumothorax</measure>
    <time_frame>in the first 72 hours after birth</time_frame>
    <description>Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Pulmonary Interstitial Emphysema</measure>
    <time_frame>in the first 72 hours of life</time_frame>
    <description>Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Cranial Ultrasound Findings</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Endotracheal Ventilation</measure>
    <time_frame>days through study completion, an average of 4 months</time_frame>
    <description>Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Non-invasive Ventilation</measure>
    <time_frame>days through study completion, an average of 4 months</time_frame>
    <description>Duration of non-invasive ventilation, days through study completion, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Supplemental Oxygen Therapy</measure>
    <time_frame>days through study completion, an average of 4 months</time_frame>
    <description>Duration of supplemental oxygen therapy days through study completion, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Duration of Assisted Ventilation</measure>
    <time_frame>through study completion, an average of 4 months</time_frame>
    <description>Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia</measure>
    <time_frame>at 36 weeks corrected gestational age</time_frame>
    <description>Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Mortality</measure>
    <time_frame>from time of birth until discharge from hospital, up to 44 weeks corrected gestational age</time_frame>
    <description>Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite Outcome of Death or BPD</measure>
    <time_frame>BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first</time_frame>
    <description>Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Retinopathy of Prematurity Requiring Treatment</measure>
    <time_frame>before hospital discharge, an average of 4 months</time_frame>
    <description>Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Diagnosis of Necrotizing Enterocolitis</measure>
    <time_frame>before hospital discharge, an average of 4 months</time_frame>
    <description>Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Fluid Boluses for Circulatory Support</measure>
    <time_frame>within the first 3 days of life</time_frame>
    <description>Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Endotracheal Intubation in the NICU</measure>
    <time_frame>in the first 24 hours of life</time_frame>
    <description>Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Mortality in the Delivery Room</measure>
    <time_frame>from time of birth until transfer to NICU</time_frame>
    <description>Neonatal Mortality in the delivery room from time of birth until transfer to NICU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">288</enrollment>
  <condition>Resuscitation</condition>
  <condition>Neonatal Prematurity</condition>
  <condition>Positive-Pressure Respiration</condition>
  <arm_group>
    <arm_group_label>RFM visible</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RFM masked</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>New Life Box Respiratory Function Monitor</intervention_name>
    <description>The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
    <arm_group_label>RFM visible</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical&#xD;
&#xD;
          -  Receive positive pressure ventilation during delivery room resuscitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known major anomalies including that may affect measured cardiorespiratory parameters:&#xD;
             congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease,&#xD;
             pulmonary hypoplasia&#xD;
&#xD;
          -  RFM not available during resuscitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Weeks</minimum_age>
    <maximum_age>28 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arjan te Pas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.</citation>
    <PMID>18192329</PMID>
  </reference>
  <reference>
    <citation>Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.</citation>
    <PMID>19776023</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>November 2, 2020</results_first_submitted>
  <results_first_submitted_qc>December 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2021</results_first_posted>
  <disposition_first_submitted>February 18, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>December 23, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 19, 2021</disposition_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Elizabeth Foglia</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Resuscitation</keyword>
  <keyword>Neonatal Prematurity</keyword>
  <keyword>Positive-Pressure Ventilation</keyword>
  <keyword>Respiratory Function Monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03256578/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03256578/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment occurred between Oct 2013-May 2019 in 7 NICUs in 6 Countries (Netherlands, Australia, Germany, Spain, Italy, and the United States). IRBs at each site approved the study. At five of the seven non-US sites, deferred consent was endorsed for use when there was insufficient time for antenatal consent, or it was considered inappropriate.</recruitment_details>
      <pre_assignment_details>Infants with antenatal enrollment into the trial were excluded from randomization if their delivery occurred outside of the gestational age eligibility window.Post-randomization exclusion occurred if postnatal consent was not obtained, no IPPV delivered, equipment failure, or a congenital anomaly was discovered.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>RFM Visible</title>
          <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
        </group>
        <group group_id="P2">
          <title>RFM Masked</title>
          <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="206"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Excluded Post Randomization</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RFM Visible</title>
          <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
        </group>
        <group group_id="B2">
          <title>RFM Masked</title>
          <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="138"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="288"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Gestational age in weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" lower_limit="25" upper_limit="27"/>
                    <measurement group_id="B2" value="26" lower_limit="25" upper_limit="27"/>
                    <measurement group_id="B3" value="26" lower_limit="25" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="138"/>
                    <count group_id="B2" value="150"/>
                    <count group_id="B3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg</title>
        <description>To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe &quot;safe range&quot; of 4 - 8 mls/kg.</description>
        <time_frame>the first 15 minutes of resuscitation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg</title>
          <description>To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe &quot;safe range&quot; of 4 - 8 mls/kg.</description>
          <units>percentage of inflations</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Total inflations</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Total inflations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25432"/>
                <count group_id="O2" value="25920"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2" lower_limit="18.0" upper_limit="41.6"/>
                    <measurement group_id="O2" value="30.7" lower_limit="15.8" upper_limit="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.896</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life</title>
        <description>Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life</description>
        <time_frame>approximately first 5 minutes of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life</title>
          <description>Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life</description>
          <units>percentage of oxygen saturation</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" lower_limit="46" upper_limit="71"/>
                    <measurement group_id="O2" value="63" lower_limit="52" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.107</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heart Rate in the First 10 Minutes of Life</title>
        <description>Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life</description>
        <time_frame>between 3 and 10 minutes of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate in the First 10 Minutes of Life</title>
          <description>Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life</description>
          <units>beats per minute</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144" lower_limit="130" upper_limit="156"/>
                    <measurement group_id="O2" value="143" lower_limit="127" upper_limit="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.847</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Mask Leak During PPV Ventilation</title>
        <description>Percentage of time with significant mask leak (defined as &gt; 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.</description>
        <time_frame>approximately first 15 minutes of resuscitation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Mask Leak During PPV Ventilation</title>
          <description>Percentage of time with significant mask leak (defined as &gt; 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.</description>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="7.2" upper_limit="33.3"/>
                    <measurement group_id="O2" value="13.6" lower_limit="3.7" upper_limit="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.126</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of PPV Inflations With Airway Obstruction</title>
        <description>Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte &lt;1 mL/kg, with minimal mask leak (&lt;25%) during an inflation and flattening of the flow waves.</description>
        <time_frame>approximately first 15 minutes of resuscitation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of PPV Inflations With Airway Obstruction</title>
          <description>Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte &lt;1 mL/kg, with minimal mask leak (&lt;25%) during an inflation and flattening of the flow waves.</description>
          <units>percentage of inflations</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.346</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of PPV Inflations With Inadequate Tidal Volume</title>
        <description>Percentage of PPV inflations with inadequate tidal volume defined as Vte &lt;4 ml/kg in the first 15 minutes of resuscitation.</description>
        <time_frame>approximately first 15 minutes of resuscitation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of PPV Inflations With Inadequate Tidal Volume</title>
          <description>Percentage of PPV inflations with inadequate tidal volume defined as Vte &lt;4 ml/kg in the first 15 minutes of resuscitation.</description>
          <units>percentage of inflations</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7" lower_limit="20.5" upper_limit="62.4"/>
                    <measurement group_id="O2" value="34.1" lower_limit="18.5" upper_limit="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.094</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life</title>
        <description>Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life</description>
        <time_frame>Between 3 and 10 minutes of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life</title>
          <description>Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life</description>
          <units>percentage of oxygen saturation</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="74" upper_limit="89"/>
                    <measurement group_id="O2" value="85" lower_limit="75" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.656</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life</title>
        <description>Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life</description>
        <time_frame>between 3 and 10 minutes of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life</title>
          <description>Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life</description>
          <units>percentage fraction of inspired oxygen</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="36" upper_limit="74"/>
                    <measurement group_id="O2" value="49" lower_limit="36" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.434</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life</title>
        <description>Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.</description>
        <time_frame>approximately first 10 minutes of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life</title>
          <description>Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.</description>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="13.2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.903</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Receiving Endotracheal Intubation in the Delivery Room</title>
        <description>Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU</description>
        <time_frame>from time of birth to admission to NICU</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving Endotracheal Intubation in the Delivery Room</title>
          <description>Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.699</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Inotropes for Circulatory Support</title>
        <description>Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth</description>
        <time_frame>within the first 3 days after birth</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Inotropes for Circulatory Support</title>
          <description>Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.231</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Pneumothorax</title>
        <description>Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention</description>
        <time_frame>in the first 72 hours after birth</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pneumothorax</title>
          <description>Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.283</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.593</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.225</ci_lower_limit>
            <ci_upper_limit>1.561</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Pulmonary Interstitial Emphysema</title>
        <description>Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention</description>
        <time_frame>in the first 72 hours of life</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pulmonary Interstitial Emphysema</title>
          <description>Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.168</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.864</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.756</ci_lower_limit>
            <ci_upper_limit>4.599</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Cranial Ultrasound Findings</title>
        <description>Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months</description>
        <time_frame>through study completion, an average of 4 months</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Cranial Ultrasound Findings</title>
          <description>Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.024</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.670</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.474</ci_lower_limit>
            <ci_upper_limit>0.947</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Endotracheal Ventilation</title>
        <description>Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months</description>
        <time_frame>days through study completion, an average of 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Endotracheal Ventilation</title>
          <description>Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="1" upper_limit="20"/>
                    <measurement group_id="O2" value="6" lower_limit="1" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.585</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Non-invasive Ventilation</title>
        <description>Duration of non-invasive ventilation, days through study completion, an average of 4 months</description>
        <time_frame>days through study completion, an average of 4 months</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Non-invasive Ventilation</title>
          <description>Duration of non-invasive ventilation, days through study completion, an average of 4 months</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" lower_limit="29" upper_limit="56"/>
                    <measurement group_id="O2" value="37" lower_limit="16" upper_limit="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.342</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Supplemental Oxygen Therapy</title>
        <description>Duration of supplemental oxygen therapy days through study completion, an average of 4 months</description>
        <time_frame>days through study completion, an average of 4 months</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Supplemental Oxygen Therapy</title>
          <description>Duration of supplemental oxygen therapy days through study completion, an average of 4 months</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" lower_limit="15" upper_limit="77"/>
                    <measurement group_id="O2" value="35" lower_limit="8" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.431</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Duration of Assisted Ventilation</title>
        <description>Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months</description>
        <time_frame>through study completion, an average of 4 months</time_frame>
        <population>Outcome measure was not analyzed as the way the data was collected did not allow for a total calculation of all assisted ventilation. (Data collected at all centers provided the data in days (defined as minimum of 6 hours per day) separately for mechanical and non-invasive ventilation, therefore even a total estimation in days may not be representative).</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Duration of Assisted Ventilation</title>
          <description>Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months</description>
          <population>Outcome measure was not analyzed as the way the data was collected did not allow for a total calculation of all assisted ventilation. (Data collected at all centers provided the data in days (defined as minimum of 6 hours per day) separately for mechanical and non-invasive ventilation, therefore even a total estimation in days may not be representative).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia</title>
        <description>Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support</description>
        <time_frame>at 36 weeks corrected gestational age</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia</title>
          <description>Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No BPD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.518</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.059</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.854</ci_lower_limit>
            <ci_upper_limit>1.313</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neonatal Mortality</title>
        <description>Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first</description>
        <time_frame>from time of birth until discharge from hospital, up to 44 weeks corrected gestational age</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Neonatal Mortality</title>
          <description>Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.855</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.951</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.555</ci_lower_limit>
            <ci_upper_limit>1.629</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Composite Outcome of Death or BPD</title>
        <description>Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age</description>
        <time_frame>BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Outcome of Death or BPD</title>
          <description>Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.524</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.994</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.834</ci_lower_limit>
            <ci_upper_limit>1.186</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Retinopathy of Prematurity Requiring Treatment</title>
        <description>Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months</description>
        <time_frame>before hospital discharge, an average of 4 months</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Retinopathy of Prematurity Requiring Treatment</title>
          <description>Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.280</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.649</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.294</ci_lower_limit>
            <ci_upper_limit>1.434</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Diagnosis of Necrotizing Enterocolitis</title>
        <description>Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months</description>
        <time_frame>before hospital discharge, an average of 4 months</time_frame>
        <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Diagnosis of Necrotizing Enterocolitis</title>
          <description>Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months</description>
          <population>1 infant in the RFM masked arm died in the delivery room and therefore did not have NICU data available to contribute to this secondary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.339</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.393</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.703</ci_lower_limit>
            <ci_upper_limit>2.760</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Fluid Boluses for Circulatory Support</title>
        <description>Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life</description>
        <time_frame>within the first 3 days of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Fluid Boluses for Circulatory Support</title>
          <description>Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.486</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Endotracheal Intubation in the NICU</title>
        <description>Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life</description>
        <time_frame>in the first 24 hours of life</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Endotracheal Intubation in the NICU</title>
          <description>Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.655</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neonatal Mortality in the Delivery Room</title>
        <description>Neonatal Mortality in the delivery room from time of birth until transfer to NICU</description>
        <time_frame>from time of birth until transfer to NICU</time_frame>
        <group_list>
          <group group_id="O1">
            <title>RFM Visible</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
          </group>
          <group group_id="O2">
            <title>RFM Masked</title>
            <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
          </group>
        </group_list>
        <measure>
          <title>Neonatal Mortality in the Delivery Room</title>
          <description>Neonatal Mortality in the delivery room from time of birth until transfer to NICU</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored from the time of birth (in the delivery room) to the time of transfer to the Neonatal Intensive Care Unit. All cause mortality was documented from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first.</time_frame>
      <desc>Need for positive pressure after birth is an inclusion criterion for this study, therefore respiratory failure requiring PPV or endotracheal intubation after birth was not considered an adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>RFM Visible</title>
          <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.&#xD;
New Life Box Respiratory Function Monitor: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.</description>
        </group>
        <group group_id="E2">
          <title>RFM Masked</title>
          <description>During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Compressions</sub_title>
                <description>Chest Compressions during neonatal resuscitation in the delivery room</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Adrenaline</sub_title>
                <description>Adrenaline during neonatal resuscitation in the delivery room</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Arjan te Pas</name_or_title>
      <organization>Leiden University Medical Center</organization>
      <phone>+31 71 5265839</phone>
      <email>a.b.te_pas@lumc.nl</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03256578
org study id: 826695
secondary id: NTR4104
nct id: NCT03256578
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a randomized trial to determine if a visible respiratory function monitor (RFM)
      displaying realtime measurements of delivered inflations improves clinical providers ability
      to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in
      preterm infants after birth.
Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can
      guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life
      Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure
      and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New
      Life Box uses a small variable orifice anemometer to measure gas flow in and out of a
      face-mask or endotracheal tube. This signal is automatically integrated to provide inspired
      (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or
      endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from
      the infant is seen during a positive pressure inflation. The RFM can also calculate and
      measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all
      ventilation pressures. Using customized software heart rate, oxygen saturation and expired
      carbon dioxide can be integrated into the RFM.

      The NewLife Box monitor presents graphical information for pressure, flow, and volume. In
      addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti,
      Vte), flow, respiratory rate and percent leak. The monitor integrates and displays
      physiologic data streaming from the patient (heart rate and oxygen saturation) as well as
      FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled,
      the monitor can incorporate video captured from an external camera. The video serves as a
      helpful aid in the interpretation of the events during the RFM waveform recordings.

      The use of an RFM in the DR has the potential to improve neonatal respiratory support and
      reduce lung injury.

      The primary objective of this study is to test the hypothesis that observing the data and
      waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks
      gestation) after birth will increase the proportion of inflations performed with a predefined
      VTe "safe range" of 4 - 8 mls/kg.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: The waveform data and videos captured during the study intervention will be centralized to Leiden University Medical Center. The team at Leiden University Medical Center assessing the outcomes will be will be blinded to the randomization allocation of the infant.
measure: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg
time frame: the first 15 minutes of resuscitation
description: To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
measure: Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life
time frame: approximately first 5 minutes of life
description: Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life
measure: Heart Rate in the First 10 Minutes of Life
time frame: between 3 and 10 minutes of life
description: Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life
measure: Percentage of Time With Mask Leak During PPV Ventilation
time frame: approximately first 15 minutes of resuscitation
description: Percentage of time with significant mask leak (defined as > 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.
measure: Percentage of PPV Inflations With Airway Obstruction
time frame: approximately first 15 minutes of resuscitation
description: Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte <1 mL/kg, with minimal mask leak (<25%) during an inflation and flattening of the flow waves.
measure: Percentage of PPV Inflations With Inadequate Tidal Volume
time frame: approximately first 15 minutes of resuscitation
description: Percentage of PPV inflations with inadequate tidal volume defined as Vte <4 ml/kg in the first 15 minutes of resuscitation.
measure: Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life
time frame: Between 3 and 10 minutes of life
description: Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life
measure: Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life
time frame: between 3 and 10 minutes of life
description: Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life
measure: Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life
time frame: approximately first 10 minutes of life
description: Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.
measure: Number of Participants Receiving Endotracheal Intubation in the Delivery Room
time frame: from time of birth to admission to NICU
description: Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU
measure: Number of Participants Requiring Inotropes for Circulatory Support
time frame: within the first 3 days after birth
description: Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth
measure: Number of Participants With Pneumothorax
time frame: in the first 72 hours after birth
description: Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention
measure: Number of Participants With Pulmonary Interstitial Emphysema
time frame: in the first 72 hours of life
description: Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention
measure: Number of Participants With Abnormal Cranial Ultrasound Findings
time frame: through study completion, an average of 4 months
description: Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months
measure: Duration of Endotracheal Ventilation
time frame: days through study completion, an average of 4 months
description: Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months
measure: Duration of Non-invasive Ventilation
time frame: days through study completion, an average of 4 months
description: Duration of non-invasive ventilation, days through study completion, an average of 4 months
measure: Duration of Supplemental Oxygen Therapy
time frame: days through study completion, an average of 4 months
description: Duration of supplemental oxygen therapy days through study completion, an average of 4 months
measure: Total Duration of Assisted Ventilation
time frame: through study completion, an average of 4 months
description: Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months
measure: Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia
time frame: at 36 weeks corrected gestational age
description: Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support
measure: Neonatal Mortality
time frame: from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
description: Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
measure: Composite Outcome of Death or BPD
time frame: BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
description: Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age
measure: Number of Participants With Retinopathy of Prematurity Requiring Treatment
time frame: before hospital discharge, an average of 4 months
description: Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months
measure: Number of Participants With a Diagnosis of Necrotizing Enterocolitis
time frame: before hospital discharge, an average of 4 months
description: Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months
measure: Number of Participants Requiring Fluid Boluses for Circulatory Support
time frame: within the first 3 days of life
description: Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life
measure: Number of Participants With Endotracheal Intubation in the NICU
time frame: in the first 24 hours of life
description: Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life
measure: Neonatal Mortality in the Delivery Room
time frame: from time of birth until transfer to NICU
description: Neonatal Mortality in the delivery room from time of birth until transfer to NICU
arm group label: RFM visible
arm group type: Experimental
description: During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.
arm group label: RFM masked
arm group type: No Intervention
description: During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.
intervention type: Device
intervention name: New Life Box Respiratory Function Monitor
description: The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.
arm group label: RFM visible
criteria: 
gender: All
minimum age: 24 Weeks
maximum age: 28 Weeks
healthy volunteers: No
last name: Arjan te Pas, MD
role: Principal Investigator
affiliation: Leiden University Medical Center
facility: 
country: United States
citation: Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.
PMID: 18192329
citation: Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.
PMID: 19776023
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Elizabeth Foglia
investigator title: Assistant Professor of Pediatrics
mesh term: Premature Birth
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 