<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/NCT03292562</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-17-0334</org_study_id>
    <nct_id>NCT03292562</nct_id>
  </id_info>
  <brief_title>A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants &lt;30 Weeks Gestation</brief_title>
  <official_title>A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants &lt;30 Weeks Gestation - a Feasibility Study</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>
    <has_dmc>No</has_dmc>
    <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 if among infants &lt;30 weeks gestational age on nasal&#xD;
      continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual&#xD;
      reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning&#xD;
      off CPAP when compared to discontinuing CPAP without weaning pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Days on NCPAP or Mechanical Ventilation</measure>
    <time_frame>from randomization until 28 days post-randomization</time_frame>
    <description>Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Endotracheal Ventilation</measure>
    <time_frame>from randomization until 28 days post-randomization</time_frame>
    <description>Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Failed to Wean Off NCPAP</measure>
    <time_frame>from randomization until discharge (about 92 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Developed Bronchopulmonary Dysplasia</measure>
    <time_frame>from randomization until discharge (about 92 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Developed Necrotizing Enterocolitis</measure>
    <time_frame>from randomization until discharge (about 92 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth</measure>
    <time_frame>from randomization until discharge (about 92 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>from admission to hospital until discharge (about 92 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Developed Air Leak Disorders</measure>
    <time_frame>from randomization until discharge (about 92 days)</time_frame>
    <description>Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Apnea of Prematurity</condition>
  <condition>Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Discontinue NCPAP after weaning pressures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinue NCPAP without weaning pressures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Discontinue NCPAP after weaning pressures</intervention_name>
    <description>After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).</description>
    <arm_group_label>Discontinue NCPAP after weaning pressures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Discontinue NCPAP without weaning pressures</intervention_name>
    <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).</description>
    <arm_group_label>Discontinue NCPAP without weaning pressures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All infants &lt; 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily&#xD;
&#xD;
          -  Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 &lt;/=0.25 and&#xD;
             stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to&#xD;
             no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag&#xD;
             mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for&#xD;
             previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major congenital anomalies including congenital heart disease&#xD;
&#xD;
          -  Anomalies that prevent discontinuation of NCPAP&#xD;
&#xD;
          -  Undergoing current evaluation for and/or treatment of sepsis&#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>Brittany Duyka, 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>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>February 29, 2020</results_first_submitted>
  <results_first_submitted_qc>February 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2020</results_first_posted>
  <last_update_submitted>February 29, 2020</last_update_submitted>
  <last_update_submitted_qc>February 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 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>Amir Mustafa Khan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
  <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>November 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03292562/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Discontinue NCPAP After Weaning Pressures</title>
          <description>After randomization, continuous positive airway pressure (CPAP) will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2).</description>
        </group>
        <group group_id="P2">
          <title>Discontinue NCPAP Without Weaning Pressures</title>
          <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter (1L) flow, 30% FiO2).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Discontinue NCPAP After Weaning Pressures</title>
          <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
        </group>
        <group group_id="B2">
          <title>Discontinue NCPAP Without Weaning Pressures</title>
          <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</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="35"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>corrected gestational age (in weeks) is reported</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.4" lower_limit="26.1" upper_limit="42.4"/>
                    <measurement group_id="B2" value="31.1" lower_limit="27.3" upper_limit="35.2"/>
                    <measurement group_id="B3" value="31.3" lower_limit="26.1" upper_limit="42.4"/>
                  </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="35"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Days on NCPAP or Mechanical Ventilation</title>
        <description>Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.</description>
        <time_frame>from randomization until 28 days post-randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days on NCPAP or Mechanical Ventilation</title>
          <description>Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" lower_limit="14.2" upper_limit="20.4"/>
                    <measurement group_id="O2" value="12.3" lower_limit="8.9" upper_limit="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Endotracheal Ventilation</title>
        <description>Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.</description>
        <time_frame>from randomization until 28 days post-randomization</time_frame>
        <population>Data for this measure was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Endotracheal Ventilation</title>
          <description>Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.</description>
          <population>Data for this measure was not collected.</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 Who Failed to Wean Off NCPAP</title>
        <time_frame>from randomization until discharge (about 92 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Failed to Wean Off NCPAP</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="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Developed Bronchopulmonary Dysplasia</title>
        <time_frame>from randomization until discharge (about 92 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Bronchopulmonary Dysplasia</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="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Developed Necrotizing Enterocolitis</title>
        <time_frame>from randomization until discharge (about 92 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Necrotizing Enterocolitis</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="35"/>
                <count group_id="O2" value="31"/>
              </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>Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth</title>
        <time_frame>from randomization until discharge (about 92 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth</title>
          <units>number of days of life</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" lower_limit="69" upper_limit="88"/>
                    <measurement group_id="O2" value="73" lower_limit="64" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <time_frame>from admission to hospital until discharge (about 92 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" lower_limit="80" upper_limit="102.4"/>
                    <measurement group_id="O2" value="93.3" lower_limit="77.8" upper_limit="108.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Developed Air Leak Disorders</title>
        <description>Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.</description>
        <time_frame>from randomization until discharge (about 92 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Discontinue NCPAP After Weaning Pressures</title>
            <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
          </group>
          <group group_id="O2">
            <title>Discontinue NCPAP Without Weaning Pressures</title>
            <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Air Leak Disorders</title>
          <description>Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.</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="35"/>
                <count group_id="O2" value="31"/>
              </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_list>

    <reported_events>
      <time_frame>from randomization until discharge (about 92 days)</time_frame>
      <desc>Only events thought to be related to the intervention are considered to be adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Discontinue NCPAP After Weaning Pressures</title>
          <description>After randomization, CPAP pressure will be weaned by 1 every 24 hrs as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP after weaning pressures: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again.</description>
        </group>
        <group group_id="E2">
          <title>Discontinue NCPAP Without Weaning Pressures</title>
          <description>After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).&#xD;
Discontinue NCPAP without weaning pressures: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).</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="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </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>
    <point_of_contact>
      <name_or_title>Amir Khan, MD</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>713-500-5519</phone>
      <email>Amir.M.Khan@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/NCT03292562
org study id: HSC-MS-17-0334
nct id: NCT03292562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal
      continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual
      reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning
      off CPAP when compared to discontinuing CPAP without weaning pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Days on NCPAP or Mechanical Ventilation
time frame: from randomization until 28 days post-randomization
description: Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
measure: Duration of Endotracheal Ventilation
time frame: from randomization until 28 days post-randomization
description: Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.
measure: Number of Participants Who Failed to Wean Off NCPAP
time frame: from randomization until discharge (about 92 days)
measure: Number of Participants Who Developed Bronchopulmonary Dysplasia
time frame: from randomization until discharge (about 92 days)
measure: Number of Participants Who Developed Necrotizing Enterocolitis
time frame: from randomization until discharge (about 92 days)
measure: Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
time frame: from randomization until discharge (about 92 days)
measure: Length of Hospital Stay
time frame: from admission to hospital until discharge (about 92 days)
measure: Number of Participants Who Developed Air Leak Disorders
time frame: from randomization until discharge (about 92 days)
description: Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
arm group label: Discontinue NCPAP after weaning pressures
arm group type: Active Comparator
description: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
arm group label: Discontinue NCPAP without weaning pressures
arm group type: Active Comparator
description: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
intervention type: Device
intervention name: Discontinue NCPAP after weaning pressures
description: After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
arm group label: Discontinue NCPAP after weaning pressures
intervention type: Device
intervention name: Discontinue NCPAP without weaning pressures
description: After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
arm group label: Discontinue NCPAP without weaning pressures
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Brittany Duyka, 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: Amir Mustafa Khan
investigator title: Professor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 