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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01717625

Acronym

BPD

Enrollment

Registered

2012-10-30

Start date

2011-11-30

Completion date

2013-10-31

Last updated

2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

montelukast, BPD, singulair, prematurity

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.

Interventions

DRUGMontelukast

a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 10 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026