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

Phase 2

Completed

• Conditions: Bronchopulmonary Dysplasia; Infant, Very Low Birth Weight; Premature Birth
• Interventions: Drug: Montelukast

• Registration Number: NCT01717625
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-30
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montelukast	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

Primary Outcome Measures

Name	Time	Method
Incidence of moderate to severe BPD or mortality	corrected gestational age	At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality

Secondary Outcome Measures

Name	Time	Method
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event	1, 2, 4 weeks since starting study

Trial Locations

Locations (1)

Ajou university medical center; 🇰🇷 Suwon, Woncheon-dong, Yeongtong-gu,, Korea, Republic of