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

February 9, 2015 updated by: Lee Janghoon, Ajou University School of Medicine

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Woncheon-dong, Yeongtong-gu,
      • Suwon, Woncheon-dong, Yeongtong-gu,, Korea, Republic of, 443-721
        • Ajou University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: Montelukast
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
Other Names:
  • Singulair
NO_INTERVENTION: Control
Standard treatment of BPD and preterm infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of moderate to severe BPD or mortality
Time Frame: corrected gestational age
At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality
corrected gestational age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Collaborators

Seoul National University Hospital
Korea University
Gangnam Severance Hospital
Severance Hospital

Investigators

  • Study Chair: Moonsung Park, professor, Ajou University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (ESTIMATE)

October 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-CT2-11-242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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