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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Collaborators: Gangnam Severance Hospital; Korea University; Seoul National University Hospital; Severance Hospital
• Treatments: Montelukast

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