Brief Title
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Official Title
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Incidence of moderate to severe BPD or mortality
Secondary Outcome
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event
Condition
Premature Birth
Intervention
Montelukast
Study Arms / Comparison Groups
Montelukast
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
72
Start Date
November 2011
Completion Date
October 2013
Primary Completion Date
October 2013
Eligibility Criteria
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
Gender
All
Ages
N/A - 10 Weeks
Accepts Healthy Volunteers
No
Contacts
Moonsung Park, professor, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01717625
Organization ID
AJIRB-MED-CT2-11-242
Responsible Party
Principal Investigator
Study Sponsor
Ajou University School of Medicine
Collaborators
Severance Hospital
Study Sponsor
Moonsung Park, professor, Study Chair, Ajou University Medical Center
Verification Date
February 2015