<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/NCT02249143</url>
  </required_header>
  <id_info>
    <org_study_id>eIRB00010607</org_study_id>
    <nct_id>NCT02249143</nct_id>
  </id_info>
  <brief_title>Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants</brief_title>
  <official_title>Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to quantify and compare changes in lung volumes (as measured&#xD;
      by functional residual capacity) in premature infants stable on continuous positive airway&#xD;
      pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room&#xD;
      air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an&#xD;
      increased functional residual capacity (at the end of the two week study period and prior to&#xD;
      discharge) compared to those randomized to room air.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants</measure>
    <time_frame>Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).</time_frame>
    <description>Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation &lt;10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurements of Passive Respiratory Compliance in Randomized Premature Infants</measure>
    <time_frame>Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age</time_frame>
    <description>Measurements of passive respiratory compliance will be done with the single breath occlusion technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Passive Respiratory Resistance in Randomized Premature Infants</measure>
    <time_frame>Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.</time_frame>
    <description>Measurements of passive respiratory resistance will be done with the single breath occlusion technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.</measure>
    <time_frame>Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.</time_frame>
    <description>Characteristics of tidal flow volume loops will be measured.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in the Growth Parameters Between the Randomized Premature Infants</measure>
    <time_frame>From randomization through discharge at about 35-37 weeks of corrected gestational age.</time_frame>
    <description>Changes in growth parameters will be compared between randomized groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.</measure>
    <time_frame>From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).</time_frame>
    <description>Adverse events and serious adverse events occurring in the randomized groups will be documented carefully</description>
  </other_outcome>
  <other_outcome>
    <measure>Corrected Gestational Age at Which Full Nipple Feeds Are Achieved</measure>
    <time_frame>Randomization through discharge at about 35-37 weeks of corrected gestational age.</time_frame>
    <description>The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Wheezing Through One Year of Age</measure>
    <time_frame>Discharge through one year of corrected age</time_frame>
    <description>Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost Comparison Between Randomized Groups</measure>
    <time_frame>Through 12 months of corrected age</time_frame>
    <description>Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Days on Oxygen Between the Randomized Groups</measure>
    <time_frame>Through discharge at about 35-37 weeks of corrected gestational age</time_frame>
    <description>The days of oxygen supplementation will be compared between the groups of randomized patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Days in the Hospital</measure>
    <time_frame>Delivery through discharge at about 35-37 weeks of corrected gestational age</time_frame>
    <description>The days in the hospital will be compared between the randomized groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <arm_group>
    <arm_group_label>CPAP and room air</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Room air</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CPAP and room air</intervention_name>
    <description>Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
    <arm_group_label>CPAP and room air</arm_group_label>
    <other_name>continuous positive airway pressure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age at birth &lt;33 weeks&#xD;
&#xD;
          -  Required CPAP for a minimum of 24 hours for respiratory distress&#xD;
&#xD;
          -  Patient on CPAP and room air at time of randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complex congenital heart disease other than patent ductus arteriosus or atrial septal&#xD;
             defect&#xD;
&#xD;
          -  Major malformations or chromosomal anomalies&#xD;
&#xD;
          -  Multiple gestation greater than twins&#xD;
&#xD;
          -  Culture proven sepsis or unstable at time of randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy T McEvoy, MD, MCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>October 16, 2018</results_first_submitted>
  <results_first_submitted_qc>October 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2018</results_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Cynthia McEvoy</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Continuous positive airway pressure</keyword>
  <keyword>Prematurity</keyword>
  <keyword>Respiratory distress syndrome</keyword>
  <keyword>Bronchopulmonary dysplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CPAP and Room Air</title>
          <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
        </group>
        <group group_id="P2">
          <title>Room Air</title>
          <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="26">randomized</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22">with technically acceptable pulmonary function tests in the neonatal intensive care unit</participants>
                <participants group_id="P2" count="22">with technically acceptable pulmonary function tests in the neonatal intensive care unit</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Comparator: CPAP and Room Air</title>
          <description>CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
        </group>
        <group group_id="B2">
          <title>No Intervention: Room Air</title>
          <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</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="22"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="13"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="23"/>
                  </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="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants</title>
        <description>Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation &lt;10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.</description>
        <time_frame>Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants</title>
          <description>Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation &lt;10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FRC change from baseline to two weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="11.4"/>
                    <measurement group_id="O2" value="6.4" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FRC change from baseline to discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="12.5"/>
                    <measurement group_id="O2" value="17.1" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>6.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>13.22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measurements of Passive Respiratory Compliance in Randomized Premature Infants</title>
        <description>Measurements of passive respiratory compliance will be done with the single breath occlusion technique.</description>
        <time_frame>Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Measurements of Passive Respiratory Compliance in Randomized Premature Infants</title>
          <description>Measurements of passive respiratory compliance will be done with the single breath occlusion technique.</description>
          <units>mL/Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Randomization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="0.28"/>
                    <measurement group_id="O2" value="1.32" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At End of 2 Weeks of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="0.28"/>
                    <measurement group_id="O2" value="1.17" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="0.18"/>
                    <measurement group_id="O2" value="1.12" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Passive Respiratory Resistance in Randomized Premature Infants</title>
        <description>Measurements of passive respiratory resistance will be done with the single breath occlusion technique.</description>
        <time_frame>Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Passive Respiratory Resistance in Randomized Premature Infants</title>
          <description>Measurements of passive respiratory resistance will be done with the single breath occlusion technique.</description>
          <units>cmH2O/mL/sec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Randomization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.054" spread="0.014"/>
                    <measurement group_id="O2" value="0.053" spread="0.009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At End of 2 Weeks of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.061" spread="0.014"/>
                    <measurement group_id="O2" value="0.074" spread="0.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.073" spread="0.02"/>
                    <measurement group_id="O2" value="0.082" spread="0.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.</title>
        <description>Characteristics of tidal flow volume loops will be measured.</description>
        <time_frame>Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.</title>
          <description>Characteristics of tidal flow volume loops will be measured.</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Randomization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="1.1"/>
                    <measurement group_id="O2" value="7.8" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At End of 2 Weeks of Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="1.1"/>
                    <measurement group_id="O2" value="7.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="1.1"/>
                    <measurement group_id="O2" value="7.3" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Changes in the Growth Parameters Between the Randomized Premature Infants</title>
        <description>Changes in growth parameters will be compared between randomized groups.</description>
        <time_frame>From randomization through discharge at about 35-37 weeks of corrected gestational age.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in the Growth Parameters Between the Randomized Premature Infants</title>
          <description>Changes in growth parameters will be compared between randomized groups.</description>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Randomization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1567" spread="293"/>
                    <measurement group_id="O2" value="1482" spread="323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2282" spread="354"/>
                    <measurement group_id="O2" value="2253" spread="413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.</title>
        <description>Adverse events and serious adverse events occurring in the randomized groups will be documented carefully</description>
        <time_frame>From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.</title>
          <description>Adverse events and serious adverse events occurring in the randomized groups will be documented carefully</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </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>Other Pre-specified</type>
        <title>Corrected Gestational Age at Which Full Nipple Feeds Are Achieved</title>
        <description>The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.</description>
        <time_frame>Randomization through discharge at about 35-37 weeks of corrected gestational age.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Corrected Gestational Age at Which Full Nipple Feeds Are Achieved</title>
          <description>The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.</description>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" lower_limit="35.1" upper_limit="37.5"/>
                    <measurement group_id="O2" value="35.5" lower_limit="34.7" upper_limit="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Incidence of Wheezing Through One Year of Age</title>
        <description>Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.</description>
        <time_frame>Discharge through one year of corrected age</time_frame>
        <population>Number of participants analyzed is lower here as we were not able to follow all infants through 1 year of corrected age.</population>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Wheezing Through One Year of Age</title>
          <description>Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.</description>
          <population>Number of participants analyzed is lower here as we were not able to follow all infants through 1 year of corrected age.</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="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cost Comparison Between Randomized Groups</title>
        <description>Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.</description>
        <time_frame>Through 12 months of corrected age</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Cost Comparison Between Randomized Groups</title>
          <description>Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.</description>
          <population>Data 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>Other Pre-specified</type>
        <title>Days on Oxygen Between the Randomized Groups</title>
        <description>The days of oxygen supplementation will be compared between the groups of randomized patients.</description>
        <time_frame>Through discharge at about 35-37 weeks of corrected gestational age</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Days on Oxygen Between the Randomized Groups</title>
          <description>The days of oxygen supplementation will be compared between the groups of randomized patients.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2.3"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Days in the Hospital</title>
        <description>The days in the hospital will be compared between the randomized groups.</description>
        <time_frame>Delivery through discharge at about 35-37 weeks of corrected gestational age</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>CPAP and Room Air</title>
            <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
          </group>
          <group group_id="O2">
            <title>Room Air</title>
            <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</description>
          </group>
        </group_list>
        <measure>
          <title>Days in the Hospital</title>
          <description>The days in the hospital will be compared between the randomized groups.</description>
          <population>Data 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_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>CPAP and Room Air</title>
          <description>Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.&#xD;
CPAP and room air: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.</description>
        </group>
        <group group_id="E2">
          <title>Room Air</title>
          <description>Premature stable infants on CPAP and room air will be randomized to transition to room air alone.</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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>Cindy McEvoy, MD</name_or_title>
      <organization>OHSU</organization>
      <phone>503-494-0223</phone>
      <email>mcevoyc@ohsu.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/NCT02249143
org study id: eIRB00010607
nct id: NCT02249143
lead sponsor: 
has dmc: No
The primary aim of this study is to quantify and compare changes in lung volumes (as measured
      by functional residual capacity) in premature infants stable on continuous positive airway
      pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room
      air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an
      increased functional residual capacity (at the end of the two week study period and prior to
      discharge) compared to those randomized to room air.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
time frame: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
description: Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation <10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.
measure: Measurements of Passive Respiratory Compliance in Randomized Premature Infants
time frame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age
description: Measurements of passive respiratory compliance will be done with the single breath occlusion technique.
measure: Passive Respiratory Resistance in Randomized Premature Infants
time frame: Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.
description: Measurements of passive respiratory resistance will be done with the single breath occlusion technique.
measure: Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
time frame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.
description: Characteristics of tidal flow volume loops will be measured.
measure: Changes in the Growth Parameters Between the Randomized Premature Infants
time frame: From randomization through discharge at about 35-37 weeks of corrected gestational age.
description: Changes in growth parameters will be compared between randomized groups.
measure: The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.
time frame: From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).
description: Adverse events and serious adverse events occurring in the randomized groups will be documented carefully
measure: Corrected Gestational Age at Which Full Nipple Feeds Are Achieved
time frame: Randomization through discharge at about 35-37 weeks of corrected gestational age.
description: The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.
measure: Incidence of Wheezing Through One Year of Age
time frame: Discharge through one year of corrected age
description: Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.
measure: Cost Comparison Between Randomized Groups
time frame: Through 12 months of corrected age
description: Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.
measure: Days on Oxygen Between the Randomized Groups
time frame: Through discharge at about 35-37 weeks of corrected gestational age
description: The days of oxygen supplementation will be compared between the groups of randomized patients.
measure: Days in the Hospital
time frame: Delivery through discharge at about 35-37 weeks of corrected gestational age
description: The days in the hospital will be compared between the randomized groups.
arm group label: CPAP and room air
arm group type: Active Comparator
description: Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.
arm group label: Room air
arm group type: No Intervention
description: Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
intervention type: Device
intervention name: CPAP and room air
description: Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.
arm group label: CPAP and room air
other name: continuous positive airway pressure
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
last name: Cindy T McEvoy, MD, MCR
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Cynthia McEvoy
investigator title: Professor of Pediatrics
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Bronchopulmonary Dysplasia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 