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The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia (BPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01717625
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : February 10, 2015
Sponsor:
Collaborators:
Severance Hospital
Seoul National University Hospital
Gangnam Severance Hospital
Korea University
Information provided by (Responsible Party):
Lee Janghoon, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 26, 2012
First Posted Date  ICMJE October 30, 2012
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE November 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
Incidence of moderate to severe BPD or mortality [ Time Frame: corrected gestational age ]
At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event [ Time Frame: 1, 2, 4 weeks since starting study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Official Title  ICMJE The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Premature Birth
  • Infant, Very Low Birth Weight
  • Bronchopulmonary Dysplasia
Intervention  ICMJE Drug: Montelukast
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
Other Name: Singulair
Study Arms  ICMJE
  • Experimental: Montelukast

    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
    Intervention: Drug: Montelukast
  • No Intervention: Control
    Standard treatment of BPD and preterm infants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Preterm infants born at less than 32 weeks
  • Birth 14 days after, oxygen or artificial ventilation who are using patient
  • more than 20cal/kg/d by enteral feeding
  • written consent of the parents

Exclusion Criteria:

  • congenital anomaly
  • cardiovascular collapse
  • investigator's opinion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01717625
Other Study ID Numbers  ICMJE AJIRB-MED-CT2-11-242
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lee Janghoon, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE
  • Severance Hospital
  • Seoul National University Hospital
  • Gangnam Severance Hospital
  • Korea University
Investigators  ICMJE
Study Chair: Moonsung Park, professor Ajou University Medical Center
PRS Account Ajou University School of Medicine
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP