drugset / Trial / NCT01717625
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Phase 2
Completed
72 enrolled
Ajou University School of Medicine
Gangnam Severance Hospital · collabKorea University · collabSeoul National University Hospital · collabSeverance Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2011-11
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Montelukast | Other / unclassified | 0.5 mg | — |
| Subject | Montelukast | Other / unclassified | 1 mg | — |
| Subject | Montelukast | Other / unclassified | 1.5 mg | — |
| Subject | Montelukast | Other / unclassified | 2 mg | — |