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

Ajou University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Infant, Very Low Birth Weight; Bronchopulmonary Dysplasia; Premature Birth

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT01717625

AJIRB-MED-CT2-11-242

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 2 to 10 weeks old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Montelukast

Experimental group

Description:

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

Treatment:

Drug: Montelukast

Control

No Intervention group

Description:

Standard treatment of BPD and preterm infants