<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/NCT01717625</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-CT2-11-242</org_study_id>
    <nct_id>NCT01717625</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia</brief_title>
  <acronym>BPD</acronym>
  <official_title>The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is multicentered, prospective, randomized, opened, parallel, intervention study.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the&#xD;
      prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational&#xD;
      age.&#xD;
&#xD;
      The investigators evaluate the first effectiveness through the morbidity and mortality of&#xD;
      bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness&#xD;
      through the oxygen index, the usage of mechanical ventilator about taking medicine after 2&#xD;
      Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial&#xD;
      lavage fluid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of moderate to severe BPD or mortality</measure>
    <time_frame>corrected gestational age</time_frame>
    <description>At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event</measure>
    <time_frame>1, 2, 4 weeks since starting study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Premature Birth</condition>
  <condition>Infant, Very Low Birth Weight</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <arm_group>
    <arm_group_label>Montelukast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>montelukast sodium&#xD;
dosage&#xD;
&lt; 1000g : 0.5 mg/D QD&#xD;
1000g~1500g : 1.0 mg/D QD&#xD;
1500g~2000g : 1.5 mg/D QD&#xD;
&gt; 2000g : 2mg/D QD&#xD;
medication period : to discharge or GA 36wks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment of BPD and preterm infants</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast</intervention_name>
    <description>a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source</description>
    <arm_group_label>Montelukast</arm_group_label>
    <other_name>Singulair</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants born at less than 32 weeks&#xD;
&#xD;
          -  Birth 14 days after, oxygen or artificial ventilation who are using patient&#xD;
&#xD;
          -  more than 20cal/kg/d by enteral feeding&#xD;
&#xD;
          -  written consent of the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital anomaly&#xD;
&#xD;
          -  cardiovascular collapse&#xD;
&#xD;
          -  investigator's opinion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Weeks</minimum_age>
    <maximum_age>10 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moonsung Park, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Ajou University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou university medical center</name>
      <address>
        <city>Suwon</city>
        <state>Woncheon-dong, Yeongtong-gu,</state>
        <zip>443-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>February 9, 2015</last_update_submitted>
  <last_update_submitted_qc>February 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Lee Janghoon</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>montelukast</keyword>
  <keyword>BPD</keyword>
  <keyword>singulair</keyword>
  <keyword>prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Montelukast</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01717625
org study id: AJIRB-MED-CT2-11-242
nct id: NCT01717625
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study is multicentered, prospective, randomized, opened, parallel, intervention study.

      The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the
      prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational
      age.

      The investigators evaluate the first effectiveness through the morbidity and mortality of
      bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness
      through the oxygen index, the usage of mechanical ventilator about taking medicine after 2
      Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial
      lavage fluid.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of moderate to severe BPD or mortality
time frame: corrected gestational age
description: At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality
measure: Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event
time frame: 1, 2, 4 weeks since starting study
arm group label: Montelukast
arm group type: Experimental
description: montelukast sodium
dosage
< 1000g : 0.5 mg/D QD
1000g~1500g : 1.0 mg/D QD
1500g~2000g : 1.5 mg/D QD
> 2000g : 2mg/D QD
medication period : to discharge or GA 36wks
arm group label: Control
arm group type: No Intervention
description: Standard treatment of BPD and preterm infants
intervention type: Drug
intervention name: Montelukast
description: a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
arm group label: Montelukast
other name: Singulair
criteria: 
gender: All
minimum age: 2 Weeks
maximum age: 10 Weeks
healthy volunteers: No
last name: Moonsung Park, professor
role: Study Chair
affiliation: Ajou University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Lee Janghoon
investigator title: Assistant professor
mesh term: Bronchopulmonary Dysplasia
mesh term: Premature Birth
mesh term: Birth Weight
mesh term: Montelukast