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

NCT01717625 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-02-10

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Montelukast

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

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Gangnam Severance Hospital

    collaborator OTHER

  • Korea University

    collaborator OTHER

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Moonsung Park, professor · Ajou University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01717625 on ClinicalTrials.gov