<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/NCT01709409</url>
  </required_header>
  <id_info>
    <org_study_id>Curosurf-01</org_study_id>
    <nct_id>NCT01709409</nct_id>
  </id_info>
  <brief_title>A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants</brief_title>
  <official_title>A Randomized, Controlled, Partially Double-blinded, Phase 3, Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Infants 24+0 to 31+6 Weeks Gestational Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if a medication called Curosurf can reduce the length of&#xD;
      time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,&#xD;
      stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a&#xD;
      medication that is already used in other countries around the world but not yet in Canada.&#xD;
&#xD;
      Babies born under 32 weeks of gestation frequently need respiratory support after birth,&#xD;
      including being placed on a breathing machine or respirator. The most common reason is&#xD;
      Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a&#xD;
      soapy like substance that helps the air sacs open and close. Our current standard treatment&#xD;
      is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore&#xD;
      the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be&#xD;
      able to be removed from the ventilator sooner.&#xD;
&#xD;
      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the&#xD;
      investigators will monitor their progress during their Neonatal Intensive Care Unit&#xD;
      admission.&#xD;
&#xD;
      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra&#xD;
      tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation</measure>
    <time_frame>48 hours</time_frame>
    <description>rate on ventilator ≤40 per minute and&#xD;
mean airway pressure ≤ 10 cm H20 and&#xD;
fi02 ≤ 30%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups.</measure>
    <time_frame>36 weeks GA</time_frame>
    <description>1. Extubation failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curosurf-01</measure>
    <time_frame>36 weeks GA</time_frame>
    <description>2. Duration of first intubation (in hours/days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curosurf-01</measure>
    <time_frame>36 weeks GA</time_frame>
    <description>3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curosurf-01</measure>
    <time_frame>36 weeks GA</time_frame>
    <description>4. Number of doses of surfactant received</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curosurf-01</measure>
    <time_frame>36 weeks GA</time_frame>
    <description>5. Adverse events during or after administration of surfactant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curosurf-01</measure>
    <time_frame>36 Weeks GA</time_frame>
    <description>6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curosurf-01</measure>
    <time_frame>36 weeks GA</time_frame>
    <description>7. Mortality prior to discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Curosurf (Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLES (Group 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Curosurf-Group1</intervention_name>
    <description>Maximum of 3 doses are administered to infants diagnosed with RDS.</description>
    <arm_group_label>Curosurf (Group 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLES-group 2</intervention_name>
    <description>Maximum of 3 doses are administered to infants with RDS</description>
    <arm_group_label>BLES (Group 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infants born between 24+0 and 31+6 weeks gestational age, admitted to the study&#xD;
             centers&#xD;
&#xD;
          2. Infants with RDS requiring intubation and surfactant therapy within 48 hours after&#xD;
             birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any infant more than 48 hours of age&#xD;
&#xD;
          2. Any infant with a pulmonary hemorrhage&#xD;
&#xD;
          3. Any infant with life-threatening congenital anomaly or one that is considered&#xD;
             non-viable&#xD;
&#xD;
          4. Any infant on rescue high frequency ventilation&#xD;
&#xD;
          5. Any infant known to require early intubation and ventilation for surgical treatment of&#xD;
             a congenital anomaly&#xD;
&#xD;
          6. Any infant with anomalies of the upper or lower airway or mandible precluding use of&#xD;
             nCPAP&#xD;
&#xD;
          7. Any infant born after prolonged premature rupture of membranes (&lt;22 weeks GA or &gt;28&#xD;
             days prior to delivery)&#xD;
&#xD;
          8. A parent/LAR who is incapable of, or unwilling, to give consent&#xD;
&#xD;
          9. Participation in another clinical trial of any placebo, drug, biological, or device&#xD;
             conducted under the provisions of a protocol&#xD;
&#xD;
         10. Any other reason as deemed significant by the Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Weeks</minimum_age>
    <maximum_age>31 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigitte Lemyre, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHRI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.curosurf.com/</url>
    <description>Product information</description>
  </link>
  <results_reference>
    <citation>Lemyre B, Fusch C, Schmolzer GM, Rouvinez Bouali N, Reddy D, Barrowman N, Huneault-Purney N, Lacaze-Masmonteil T. Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial. PLoS One. 2017 May 4;12(5):e0175922. doi: 10.1371/journal.pone.0175922. eCollection 2017.</citation>
    <PMID>28472058</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>June 1, 2017</results_first_submitted>
  <results_first_submitted_qc>June 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2017</results_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poractant alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Three university-affiliated tertiary NICUs recruited patients between March 2013 and December 2015. 560 patients were screening for eligibility.</recruitment_details>
      <pre_assignment_details>One patient in the Curosurf group was found to have an exclusion criteria after randomization and was excluded (he did not receive the assigned treatment).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Curosurf (Group 1)</title>
          <description>Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.</description>
        </group>
        <group group_id="P2">
          <title>BLES (Group 2)</title>
          <description>Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Infants born between 24+0 and 31+6 weeks gestational age, admitted to the study centers&#xD;
Infants with RDS requiring intubation and surfactant therapy within 48 hours after birth</population>
      <group_list>
        <group group_id="B1">
          <title>Curosurf (Group 1)</title>
          <description>Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study.&#xD;
Curosurf-Group1: Maximum of 3 doses are administered to infants diagnosed with RDS.</description>
        </group>
        <group group_id="B2">
          <title>BLES (Group 2)</title>
          <description>Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.&#xD;
BLES-group 2: Maximum of 3 doses are administered to infants with RDS</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="42"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>weeks gestational age</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.5" spread="1.5"/>
                    <measurement group_id="B2" value="26.9" spread="2.1"/>
                    <measurement group_id="B3" value="26.7" spread="1.9"/>
                  </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="42"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>fraction of inspired oxygen</title>
          <units>% of inspired oxygen</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45" lower_limit="32" upper_limit="65"/>
                    <measurement group_id="B2" value="45" lower_limit="35" upper_limit="50"/>
                    <measurement group_id="B3" value="45" lower_limit="35" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation</title>
        <description>rate on ventilator ≤40 per minute and&#xD;
mean airway pressure ≤ 10 cm H20 and&#xD;
fi02 ≤ 30%</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Curosurf (Group 1)</title>
            <description>Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.</description>
          </group>
          <group group_id="O2">
            <title>BLES (Group 2)</title>
            <description>Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation</title>
          <description>rate on ventilator ≤40 per minute and&#xD;
mean airway pressure ≤ 10 cm H20 and&#xD;
fi02 ≤ 30%</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="42"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups.</title>
        <description>1. Extubation failure</description>
        <time_frame>36 weeks GA</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Curosurf-01</title>
        <description>2. Duration of first intubation (in hours/days)</description>
        <time_frame>36 weeks GA</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Curosurf-01</title>
        <description>3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement</description>
        <time_frame>36 weeks GA</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Curosurf-01</title>
        <description>4. Number of doses of surfactant received</description>
        <time_frame>36 weeks GA</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Curosurf-01</title>
        <description>5. Adverse events during or after administration of surfactant</description>
        <time_frame>36 weeks GA</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Curosurf-01</title>
        <description>6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA</description>
        <time_frame>36 Weeks GA</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Curosurf-01</title>
        <description>7. Mortality prior to discharge</description>
        <time_frame>36 weeks GA</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Curosurf (Group 1)</title>
          <description>Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study.</description>
        </group>
        <group group_id="E2">
          <title>BLES (Group 2)</title>
          <description>Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>needing CPR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>air leak</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>severe airway obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>pulmonary hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pulmonary interstitial emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </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>Dr. Brigitte Lemyre</name_or_title>
      <organization>OHRI</organization>
      <phone>613-737-8899 ext 71882</phone>
      <email>blemyre@toh.on.ca</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/NCT01709409
org study id: Curosurf-01
nct id: NCT01709409
lead sponsor: 
has dmc: Yes
The purpose of this study is to see if a medication called Curosurf can reduce the length of
      time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS,
      stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a
      medication that is already used in other countries around the world but not yet in Canada.

      Babies born under 32 weeks of gestation frequently need respiratory support after birth,
      including being placed on a breathing machine or respirator. The most common reason is
      Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a
      soapy like substance that helps the air sacs open and close. Our current standard treatment
      is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore
      the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be
      able to be removed from the ventilator sooner.

      Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the
      investigators will monitor their progress during their Neonatal Intensive Care Unit
      admission.

      The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra
      tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this
      study.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation
time frame: 48 hours
description: rate on ventilator ≤40 per minute and
mean airway pressure ≤ 10 cm H20 and
fi02 ≤ 30%
measure: To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups.
time frame: 36 weeks GA
description: 1. Extubation failure
measure: Curosurf-01
time frame: 36 weeks GA
description: 2. Duration of first intubation (in hours/days)
measure: Curosurf-01
time frame: 36 weeks GA
description: 3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement
measure: Curosurf-01
time frame: 36 weeks GA
description: 4. Number of doses of surfactant received
measure: Curosurf-01
time frame: 36 weeks GA
description: 5. Adverse events during or after administration of surfactant
measure: Curosurf-01
time frame: 36 Weeks GA
description: 6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA
measure: Curosurf-01
time frame: 36 weeks GA
description: 7. Mortality prior to discharge
arm group label: Curosurf (Group 1)
arm group type: Experimental
description: Surfactant(Curosurf in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. The treatment dose for Curosurf® is 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There is a maximum of 3 doses in the study.
arm group label: BLES (Group 2)
arm group type: Active Comparator
description: Surfactant(BLES in this arm) is given for treatment of RDS after the diagnosis has been made by the Neonatologist. For BLES the recommended dose is 5 ml/kg. given by endotracheal method. There is a maximum of 3 doses in the study.
intervention type: Drug
intervention name: Curosurf-Group1
description: Maximum of 3 doses are administered to infants diagnosed with RDS.
arm group label: Curosurf (Group 1)
intervention type: Drug
intervention name: BLES-group 2
description: Maximum of 3 doses are administered to infants with RDS
arm group label: BLES (Group 2)
criteria: 
gender: All
minimum age: 24 Weeks
maximum age: 31 Weeks
healthy volunteers: No
last name: Brigitte Lemyre, MD
role: Principal Investigator
affiliation: OHRI
facility: 
country: Canada
url: http://www.curosurf.com/
description: Product information
citation: Lemyre B, Fusch C, Schmolzer GM, Rouvinez Bouali N, Reddy D, Barrowman N, Huneault-Purney N, Lacaze-Masmonteil T. Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial. PLoS One. 2017 May 4;12(5):e0175922. doi: 10.1371/journal.pone.0175922. eCollection 2017.
PMID: 28472058
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Poractant alfa
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 