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

Premature Birth Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01717625
Study type Interventional
Source Ajou University School of Medicine
Contact
Status Completed
Phase Phase 2
Start date November 2011
Completion date October 2013
View Details
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