NCT01717625

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 2 Weeks – 10 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth
• Infant, Very Low Birth Weight
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Montelukast	a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-10-30
• Last updated: 2015-02-10

Locations

1 site across 1 country: South Korea