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

Ajou University School of Medicine72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Premature Birth Infant, Very Low Birth Weight Bronchopulmonary Dysplasia

Interventions

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 10 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of moderate to severe BPD or mortality

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

Time frame: corrected gestational age

Secondary Outcomes

Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event

Time frame: 1, 2, 4 weeks since starting study