xml: <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/NCT06038565</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001796</org_study_id>
      <nct_id>NCT06038565</nct_id>
    </id_info>
    <brief_title>Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates</brief_title>
    <official_title>Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare late preterm newborn lung physiology when&#xD;
        supported with different continuous positive airway pressure (CPAP) devices.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Which CPAP modality provides better breathing support in newborns with respiratory&#xD;
             distress syndrome who are greater than 32 weeks gestational age?&#xD;
  &#xD;
          -  Does the lung physiology data predict the CPAP modality that will result in a shorter&#xD;
             CPAP treatment duration?&#xD;
  &#xD;
        Participants will wear a belt of electrodes on their chest (electrical impedance tomography)&#xD;
        and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while&#xD;
        switching CPAP devices. Participants will then be randomly assigned to a CPAP device to&#xD;
        support their breathing until they recover from respiratory distress syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Across centers, there is a variation in standard of care for the preferred device and&#xD;
        interface to deliver continuous positive airway pressure (CPAP) to support neonatal&#xD;
        functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly&#xD;
        delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP).&#xD;
        Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface&#xD;
        is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls&#xD;
        and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive&#xD;
        interface intended to provide complete seal.&#xD;
  &#xD;
        To provide evidence for standardization of CPAP delivery, clinical trials are needed to&#xD;
        assess which modality of CPAP delivery is optimal for neonates with respiratory distress&#xD;
        syndrome who are &gt; 32 weeks and &lt;37 weeks gestational age, an understudied population. The&#xD;
        investigators propose to use electrical impedance tomography (EIT) paired with esophageal&#xD;
        balloon manometry to assess neonatal lung physiology when supported with different modalities&#xD;
        of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs&#xD;
        B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for&#xD;
        the remainder of their respiratory distress syndrome treatment, and researchers will track&#xD;
        which modality of CPAP results in a shorter CPAP treatment period and if this is expected&#xD;
        based on the lung physiology data collected.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 19, 2023</start_date>
    <completion_date type="Anticipated">September 19, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 19, 2024</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>Lung physiology measurements with electrical impedance tomography and esophageal manometry will be collected while the participant is supported with RAM cannula ventilator CPAP followed by occlusive interface ventilator CPAP followed by occlusive interface bubble CPAP. A 1:1 block randomization of either A) physiology-based CPAP or B) one size fits all CPAP of either RAM cannula ventilator CPAP or occlusive interface bubble CPAP will be assigned to the participant. Arm B is further randomized 1:1 to either RAM cannula ventilator CPAP or occlusive interface bubble CPAP. The duration of CPAP treatment will be compared between the two arms (precision medicine approach vs standard of care) as well as compare each device and whether the physiology data would have predicted the CPAP device would have resulted in a shorter treatment period.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
      <masking_description>Given the nature of CPAP, it is not possible to mask which CPAP device the subject is supported by, but the participant, care provider, and outcomes assessor will be masked to whether the subject was randomized to arm A (the device the lung physiology assessment deemed superior for that subject) or arm B (random assignment to the CPAP device, not taking into account the subject's lung physiology).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>change in electrical impedance</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>change in average electrical impedance with each CPAP delivery modality</description>
    </primary_outcome>
    <primary_outcome>
      <measure>duration of CPAP treatment</measure>
      <time_frame>through study completion, an average of 2 weeks after the lung physiology assessment</time_frame>
      <description>compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>change in end expiratory lung impedance (arbitrary units)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>vascular pulsatility (arbitrary units)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>tidal volume (in milliliters) per weight (in kilograms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>change in minute ventilation (mL/minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>change in dynamic compliance (mL/cmH2O)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>Respiratory rate (breaths per minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>Oxygen saturation (percentage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>Abdominal circumference (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>esophageal pressure change (mm Hg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>end expiratory pressure via esophageal balloon manometry (mm Hg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product</measure>
      <time_frame>2.5 hours during the lung physiology assessment</time_frame>
      <description>pressure rate product (cm H2O / min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation</measure>
      <time_frame>through study completion, an average of 2 weeks after the lung physiology assessment</time_frame>
      <description>frequency of deviation from assigned CPAP treatment (percentage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration</measure>
      <time_frame>through study completion, an average of 2 weeks after the lung physiology assessment</time_frame>
      <description>frequency of exogenous surfactant administration (percentage)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)</measure>
      <time_frame>through study completion, an average of 2 weeks after the lung physiology assessment</time_frame>
      <description>respiratory support settings if deviated from assigned CPAP treatment (percentage)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Prematurity</condition>
    <condition>Respiratory Distress Syndrome</condition>
    <arm_group>
      <arm_group_label>Randomization to CPAP with higher change of impedance as measured by EIT. &quot;Arm A-1&quot;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar).&#xD;
  In this Arm A-1, these subjects had higher change in impedance while supported on RAM cannula ventilator CPAP</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Randomization to CPAP with higher change of impedance as measured by EIT. &quot;Arm A-2&quot;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar).&#xD;
  In this Arm A-2, these subjects had higher change in impedance while supported on occlusive mask bubble CPAP</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Randomization to standard of care - a 'one size fits all' approach. &quot;Arm B-1&quot;</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the Neonatal Intensive Care Unit (NICU) where the newborn is hospitalized.&#xD;
  In this Arm B-1, these subjects are randomized 1:1 to RAM cannula ventilator CPAP</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Randomization to standard of care - a 'one size fits all' approach. &quot;Arm B-2&quot;</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the NICU where the newborn is hospitalized.&#xD;
  In this Arm B-2, these subjects are randomized 1:1 to occlusive mask bubble CPAP</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RAM cannula ventilator CPAP</intervention_name>
      <description>RAM cannula ventilator CPAP</description>
      <arm_group_label>Randomization to CPAP with higher change of impedance as measured by EIT. &quot;Arm A-1&quot;</arm_group_label>
      <arm_group_label>Randomization to standard of care - a 'one size fits all' approach. &quot;Arm B-1&quot;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Occlusive interface bubble CPAP</intervention_name>
      <description>Occlusive interface bubble CPAP</description>
      <arm_group_label>Randomization to CPAP with higher change of impedance as measured by EIT. &quot;Arm A-2&quot;</arm_group_label>
      <arm_group_label>Randomization to standard of care - a 'one size fits all' approach. &quot;Arm B-2&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  medically stable neonates born &gt;32 0/7 weeks and &lt; 37 0/7 weeks gestational age, with&#xD;
               birth weights &gt; 1500 grams, are chronologically 12-36 hours old, and are receiving RAM&#xD;
               cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm&#xD;
               water (H2O) and Fraction of inspired oxygen (FiO2) &lt; 0.3 for the suspected diagnosis&#xD;
               of respiratory distress syndrome&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  neonates with congenital anomalies that potentially will affect respiratory&#xD;
               physiology, for example hypoplastic lungs or gastroschisis.&#xD;
  &#xD;
            -  neonates with contraindications for wearing an occlusive interface, for example&#xD;
               epidermolysis bullosa which may have risk of worsening skin integrity at the pressure&#xD;
               points of the occlusive interface, or a known small air leak that may potentially&#xD;
               develop into a large pneumothorax.&#xD;
  &#xD;
            -  neonates with contraindications for placement of esophageal balloon manometry, for&#xD;
               example hypoglycemia managed with extended feeding times greater than 30 minutes.&#xD;
  &#xD;
            -  neonates with contraindications for electrical impedance tomography, for example&#xD;
               inability to ensure contact of the electrodes on the belt with the skin on the&#xD;
               circumference of the chest due to presence of a chest tube dressing.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Hours</minimum_age>
      <maximum_age>36 Hours</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jessica E Shui, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessica E Shui, MD</last_name>
      <phone>617-724-5994</phone>
      <email>jshui@mgh.harvard.edu</email>
    </overall_contact>
    <reference>
      <citation>Prakash R, De Paoli AG, Davis PG, Oddie SJ, McGuire W. Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD015130. doi: 10.1002/14651858.CD015130.</citation>
      <PMID>37009665</PMID>
    </reference>
    <reference>
      <citation>Prakash R, De Paoli AG, Oddie SJ, Davis PG, McGuire W. Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD015129. doi: 10.1002/14651858.CD015129.</citation>
      <PMID>36374241</PMID>
    </reference>
    <reference>
      <citation>Green EA, Dawson JA, Davis PG, De Paoli AG, Roberts CT. Assessment of resistance of nasal continuous positive airway pressure interfaces. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F535-F539. doi: 10.1136/archdischild-2018-315838. Epub 2018 Dec 19.</citation>
      <PMID>30567774</PMID>
    </reference>
    <reference>
      <citation>Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH. Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001 Feb;107(2):304-8. doi: 10.1542/peds.107.2.304.</citation>
      <PMID>11158463</PMID>
    </reference>
    <reference>
      <citation>Nascimento MS, do Prado C, Costa ELV, Alcala GC, Correa LC, Rossi FS, Amato MBP, Rebello CM. Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. Pediatr Pulmonol. 2022 Nov;57(11):2681-2687. doi: 10.1002/ppul.26082. Epub 2022 Aug 17.</citation>
      <PMID>35931651</PMID>
    </reference>
    <reference>
      <citation>Seddon PC, Davis GM. Validity of esophageal pressure measurements with positive end-expiratory pressure in preterm infants. Pediatr Pulmonol. 2003 Sep;36(3):216-22. doi: 10.1002/ppul.10284.</citation>
      <PMID>12910583</PMID>
    </reference>
    <reference>
      <citation>Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016/j.jpeds.2017.04.046. Epub 2017 May 22.</citation>
      <PMID>28545875</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Jessica E Shui, MD</investigator_full_name>
      <investigator_title>Neonatologist, Assistant Professor of Pediatrics at MGH</investigator_title>
    </responsible_party>
    <keyword>continuous positive airway pressure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038565
  org study id: 2023P001796
  nct id: NCT06038565
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare late preterm newborn lung physiology when
        supported with different continuous positive airway pressure (CPAP) devices.
  
        The main questions it aims to answer are:
  
          -  Which CPAP modality provides better breathing support in newborns with respiratory
             distress syndrome who are greater than 32 weeks gestational age?
  
          -  Does the lung physiology data predict the CPAP modality that will result in a shorter
             CPAP treatment duration?
  
        Participants will wear a belt of electrodes on their chest (electrical impedance tomography)
        and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while
        switching CPAP devices. Participants will then be randomly assigned to a CPAP device to
        support their breathing until they recover from respiratory distress syndrome.
  Across centers, there is a variation in standard of care for the preferred device and
        interface to deliver continuous positive airway pressure (CPAP) to support neonatal
        functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly
        delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP).
        Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface
        is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls
        and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive
        interface intended to provide complete seal.
  
        To provide evidence for standardization of CPAP delivery, clinical trials are needed to
        assess which modality of CPAP delivery is optimal for neonates with respiratory distress
        syndrome who are > 32 weeks and <37 weeks gestational age, an understudied population. The
        investigators propose to use electrical impedance tomography (EIT) paired with esophageal
        balloon manometry to assess neonatal lung physiology when supported with different modalities
        of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs
        B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for
        the remainder of their respiratory distress syndrome treatment, and researchers will track
        which modality of CPAP results in a shorter CPAP treatment period and if this is expected
        based on the lung physiology data collected.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Lung physiology measurements with electrical impedance tomography and esophageal manometry will be collected while the participant is supported with RAM cannula ventilator CPAP followed by occlusive interface ventilator CPAP followed by occlusive interface bubble CPAP. A 1:1 block randomization of either A) physiology-based CPAP or B) one size fits all CPAP of either RAM cannula ventilator CPAP or occlusive interface bubble CPAP will be assigned to the participant. Arm B is further randomized 1:1 to either RAM cannula ventilator CPAP or occlusive interface bubble CPAP. The duration of CPAP treatment will be compared between the two arms (precision medicine approach vs standard of care) as well as compare each device and whether the physiology data would have predicted the CPAP device would have resulted in a shorter treatment period.
  primary purpose: Basic Science
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  masking description: Given the nature of CPAP, it is not possible to mask which CPAP device the subject is supported by, but the participant, care provider, and outcomes assessor will be masked to whether the subject was randomized to arm A (the device the lung physiology assessment deemed superior for that subject) or arm B (random assignment to the CPAP device, not taking into account the subject's lung physiology).
  measure: change in electrical impedance
  time frame: 2.5 hours during the lung physiology assessment
  description: change in average electrical impedance with each CPAP delivery modality
  measure: duration of CPAP treatment
  time frame: through study completion, an average of 2 weeks after the lung physiology assessment
  description: compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance
  time frame: 2.5 hours during the lung physiology assessment
  description: change in end expiratory lung impedance (arbitrary units)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility
  time frame: 2.5 hours during the lung physiology assessment
  description: vascular pulsatility (arbitrary units)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume
  time frame: 2.5 hours during the lung physiology assessment
  description: tidal volume (in milliliters) per weight (in kilograms)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation
  time frame: 2.5 hours during the lung physiology assessment
  description: change in minute ventilation (mL/minute)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance
  time frame: 2.5 hours during the lung physiology assessment
  description: change in dynamic compliance (mL/cmH2O)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate
  time frame: 2.5 hours during the lung physiology assessment
  description: Respiratory rate (breaths per minute)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation
  time frame: 2.5 hours during the lung physiology assessment
  description: Oxygen saturation (percentage)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference
  time frame: 2.5 hours during the lung physiology assessment
  description: Abdominal circumference (cm)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change
  time frame: 2.5 hours during the lung physiology assessment
  description: esophageal pressure change (mm Hg)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure
  time frame: 2.5 hours during the lung physiology assessment
  description: end expiratory pressure via esophageal balloon manometry (mm Hg)
  measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product
  time frame: 2.5 hours during the lung physiology assessment
  description: pressure rate product (cm H2O / min)
  measure: clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation
  time frame: through study completion, an average of 2 weeks after the lung physiology assessment
  description: frequency of deviation from assigned CPAP treatment (percentage)
  measure: clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration
  time frame: through study completion, an average of 2 weeks after the lung physiology assessment
  description: frequency of exogenous surfactant administration (percentage)
  measure: clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)
  time frame: through study completion, an average of 2 weeks after the lung physiology assessment
  description: respiratory support settings if deviated from assigned CPAP treatment (percentage)
  arm group label: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"
  arm group type: Experimental
  description: After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar).
  In this Arm A-1, these subjects had higher change in impedance while supported on RAM cannula ventilator CPAP
  arm group label: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"
  arm group type: Experimental
  description: After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar).
  In this Arm A-2, these subjects had higher change in impedance while supported on occlusive mask bubble CPAP
  arm group label: Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"
  arm group type: Active Comparator
  description: Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the Neonatal Intensive Care Unit (NICU) where the newborn is hospitalized.
  In this Arm B-1, these subjects are randomized 1:1 to RAM cannula ventilator CPAP
  arm group label: Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"
  arm group type: Active Comparator
  description: Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the NICU where the newborn is hospitalized.
  In this Arm B-2, these subjects are randomized 1:1 to occlusive mask bubble CPAP
  intervention type: Device
  intervention name: RAM cannula ventilator CPAP
  description: RAM cannula ventilator CPAP
  arm group label: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"
  arm group label: Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"
  intervention type: Device
  intervention name: Occlusive interface bubble CPAP
  description: Occlusive interface bubble CPAP
  arm group label: Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"
  arm group label: Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"
  criteria: 
  gender: All
  minimum age: 12 Hours
  maximum age: 36 Hours
  healthy volunteers: No
  last name: Jessica E Shui, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Jessica E Shui, MD
  phone: 617-724-5994
  email: jshui@mgh.harvard.edu
  citation: Prakash R, De Paoli AG, Davis PG, Oddie SJ, McGuire W. Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD015130. doi: 10.1002/14651858.CD015130.
  PMID: 37009665
  citation: Prakash R, De Paoli AG, Oddie SJ, Davis PG, McGuire W. Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD015129. doi: 10.1002/14651858.CD015129.
  PMID: 36374241
  citation: Green EA, Dawson JA, Davis PG, De Paoli AG, Roberts CT. Assessment of resistance of nasal continuous positive airway pressure interfaces. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F535-F539. doi: 10.1136/archdischild-2018-315838. Epub 2018 Dec 19.
  PMID: 30567774
  citation: Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH. Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001 Feb;107(2):304-8. doi: 10.1542/peds.107.2.304.
  PMID: 11158463
  citation: Nascimento MS, do Prado C, Costa ELV, Alcala GC, Correa LC, Rossi FS, Amato MBP, Rebello CM. Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. Pediatr Pulmonol. 2022 Nov;57(11):2681-2687. doi: 10.1002/ppul.26082. Epub 2022 Aug 17.
  PMID: 35931651
  citation: Seddon PC, Davis GM. Validity of esophageal pressure measurements with positive end-expiratory pressure in preterm infants. Pediatr Pulmonol. 2003 Sep;36(3):216-22. doi: 10.1002/ppul.10284.
  PMID: 12910583
  citation: Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016/j.jpeds.2017.04.046. Epub 2017 May 22.
  PMID: 28545875
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Jessica E Shui, MD
  investigator title: Neonatologist, Assistant Professor of Pediatrics at MGH
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  sharing ipd: No