The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Overview
- Phase
- Phase 2
- Intervention
- Montelukast
- Conditions
- Premature Birth
- Sponsor
- Ajou University School of Medicine
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence of moderate to severe BPD or mortality
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Lee Janghoon
Assistant professor
Ajou University School of Medicine
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
Arms & Interventions
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: Montelukast
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event(1, 2, 4 weeks since starting study)