<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/NCT03298035</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-17-0458</org_study_id>
    <nct_id>NCT03298035</nct_id>
  </id_info>
  <brief_title>A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants</brief_title>
  <official_title>A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether nasal intermittent positive pressure&#xD;
      ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight&#xD;
      infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Were Intubated</measure>
    <time_frame>28 days after randomization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Intubation</measure>
    <time_frame>28 days after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Apneic Events</measure>
    <time_frame>28 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bronchopulmonary Dysplasia (BPD)</measure>
    <time_frame>36 weeks corrected gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Necrotizing Enterocolitis (NEC)</measure>
    <time_frame>36 weeks corrected gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Air Leak Disorders</measure>
    <time_frame>36 weeks corrected gestational age</time_frame>
    <description>Air leak disorders include pneumothorax and/or pneumomediastinum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Gain</measure>
    <time_frame>36 weeks corrected gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>about 10 to 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Died</measure>
    <time_frame>until discharge (about 10 to 18 weeks) or death</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Apnea of Prematurity</condition>
  <arm_group>
    <arm_group_label>NCPAP as mode for apnea prevention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIPPV as rescue mode for apnea prevention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NCPAP as mode for apnea prevention</intervention_name>
    <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
    <arm_group_label>NCPAP as mode for apnea prevention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIPPV as rescue mode for apnea prevention</intervention_name>
    <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
    <arm_group_label>NIPPV as rescue mode for apnea prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born at &lt; 30 weeks gestational age who develop clinically significant apnea&#xD;
             while on NCPAP &gt; 6cm H2O or whose team is considering intubation due to apnea.&#xD;
             Consider clinically significant apnea as 1 or more events treated with bag-mask&#xD;
             ventilation or 3 episodes of apnea requiring stimulation within 1 hour.&#xD;
&#xD;
          -  Infants on maximum caffeine therapy (10mg/kg/day)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Major congenital anomalies including congenital heart disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Beaullieu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>70030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <results_first_submitted>December 29, 2019</results_first_submitted>
  <results_first_submitted_qc>January 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 7, 2020</results_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Catherine Claire Beaullieu</investigator_full_name>
    <investigator_title>Neonatal-Perinatal Medicine Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <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>October 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03298035/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NIPPV as Rescue Mode for Apnea Prevention</title>
          <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
        </group>
        <group group_id="P2">
          <title>NCPAP as Mode for Apnea Prevention</title>
          <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Intervention</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NIPPV as Rescue Mode for Apnea Prevention</title>
          <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
        </group>
        <group group_id="B2">
          <title>NCPAP as Mode for Apnea Prevention</title>
          <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</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="10"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Gestational age</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.8" spread="0.8"/>
                    <measurement group_id="B2" value="25.8" spread="2.2"/>
                    <measurement group_id="B3" value="25.8" spread="1.6"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Causcasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth Weight</title>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="773" spread="160.5"/>
                    <measurement group_id="B2" value="858" spread="293.4"/>
                    <measurement group_id="B3" value="835" spread="313.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight at Enrollment</title>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="920" spread="286.6"/>
                    <measurement group_id="B2" value="921" spread="204.4"/>
                    <measurement group_id="B3" value="920.6" spread="236.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Corrected Gestational Age</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.4" spread="2.5"/>
                    <measurement group_id="B2" value="28.4" spread="1.1"/>
                    <measurement group_id="B3" value="28.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Antenatal Glucocorticoid Exposure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants Who Received Surfactant</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Were Intubated</title>
        <time_frame>28 days after randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Intubated</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Intubation</title>
        <time_frame>28 days after randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Intubation</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="10.2"/>
                    <measurement group_id="O2" value="17.5" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Apneic Events</title>
        <time_frame>28 days after randomization</time_frame>
        <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Apneic Events</title>
          <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
          <units>Number of apneic events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.78" spread="3.42"/>
                    <measurement group_id="O2" value="6.22" spread="5.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bronchopulmonary Dysplasia (BPD)</title>
        <time_frame>36 weeks corrected gestational age</time_frame>
        <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bronchopulmonary Dysplasia (BPD)</title>
          <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Necrotizing Enterocolitis (NEC)</title>
        <time_frame>36 weeks corrected gestational age</time_frame>
        <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Necrotizing Enterocolitis (NEC)</title>
          <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Air Leak Disorders</title>
        <description>Air leak disorders include pneumothorax and/or pneumomediastinum.</description>
        <time_frame>36 weeks corrected gestational age</time_frame>
        <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Air Leak Disorders</title>
          <description>Air leak disorders include pneumothorax and/or pneumomediastinum.</description>
          <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Gain</title>
        <time_frame>36 weeks corrected gestational age</time_frame>
        <population>Data were not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Gain</title>
          <population>Data were not collected for this outcome measure.</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>Length of Hospital Stay</title>
        <time_frame>about 10 to 18 weeks</time_frame>
        <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <population>One participant in the NIPPV group died; therefore, this data was not collected for that participant.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136" spread="57.7"/>
                    <measurement group_id="O2" value="149" spread="67.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Died</title>
        <time_frame>until discharge (about 10 to 18 weeks) or death</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NIPPV as Rescue Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
          <group group_id="O2">
            <title>NCPAP as Mode for Apnea Prevention</title>
            <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Died</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days. Serious and other adverse events were considered as those specifically occurring during the 28-day intervention period; however, mortality was evaluated over the maximum of an 18 week duration. The patient death that occurred happened to be within the 28-day study period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NIPPV as Rescue Mode for Apnea Prevention</title>
          <description>With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.&#xD;
NIPPV as rescue mode for apnea prevention: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.</description>
        </group>
        <group group_id="E2">
          <title>NCPAP as Mode for Apnea Prevention</title>
          <description>With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.&#xD;
NCPAP as mode for apnea prevention: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This was a pragmatic trial with inherent bias, as blinding was not possible. There was a small sample size (intent was to enroll 50, but only a few of all screened qualified for escalation of care).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Catherine C. Beaullieu, MD</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>(713) 500-6044</phone>
      <email>Catherine.C.Beaullieu@uth.tmc.edu</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/NCT03298035
org study id: HSC-MS-17-0458
nct id: NCT03298035
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine whether nasal intermittent positive pressure
      ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight
      infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Were Intubated
time frame: 28 days after randomization
measure: Duration of Intubation
time frame: 28 days after randomization
measure: Number of Apneic Events
time frame: 28 days after randomization
measure: Number of Participants With Bronchopulmonary Dysplasia (BPD)
time frame: 36 weeks corrected gestational age
measure: Number of Participants With Necrotizing Enterocolitis (NEC)
time frame: 36 weeks corrected gestational age
measure: Number of Participants With Air Leak Disorders
time frame: 36 weeks corrected gestational age
description: Air leak disorders include pneumothorax and/or pneumomediastinum.
measure: Weight Gain
time frame: 36 weeks corrected gestational age
measure: Length of Hospital Stay
time frame: about 10 to 18 weeks
measure: Number of Participants Who Died
time frame: until discharge (about 10 to 18 weeks) or death
arm group label: NCPAP as mode for apnea prevention
arm group type: Active Comparator
description: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
arm group label: NIPPV as rescue mode for apnea prevention
arm group type: Experimental
description: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
intervention type: Device
intervention name: NCPAP as mode for apnea prevention
description: With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
arm group label: NCPAP as mode for apnea prevention
intervention type: Device
intervention name: NIPPV as rescue mode for apnea prevention
description: With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
arm group label: NIPPV as rescue mode for apnea prevention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Claire Beaullieu, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Catherine Claire Beaullieu
investigator title: Neonatal-Perinatal Medicine Fellow
mesh term: Apnea
mesh term: Birth Weight
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was a pragmatic trial with inherent bias, as blinding was not possible. There was a small sample size (intent was to enroll 50, but only a few of all screened qualified for escalation of care).
point of contact: 