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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01717625
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Premature Birth Infant, Very Low Birth Weight Bronchopulmonary Dysplasia Drug: Montelukast Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Study Start Date : November 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Singulair
No Intervention: Control
Standard treatment of BPD and preterm infants

Outcome Measures

Primary Outcome Measures :
  1. 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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717625

Korea, Republic of
Ajou university medical center
Suwon, Woncheon-dong, Yeongtong-gu,, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Severance Hospital
Seoul National University Hospital
Gangnam Severance Hospital
Korea University
Study Chair: Moonsung Park, professor Ajou University
More Information

Responsible Party: Lee Janghoon, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01717625     History of Changes
Other Study ID Numbers: AJIRB-MED-CT2-11-242
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Lee Janghoon, Ajou University School of Medicine:

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Premature Birth
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action