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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Severance Hospital
Seoul National University Hospital
Gangnam Severance Hospital
Korea University
Information provided by (Responsible Party):
Lee Janghoon, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01717625
First received: October 26, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Premature Birth
Infant, Very Low Birth Weight
Bronchopulmonary Dysplasia
 Drug: Montelukast
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • Incidence of moderate to severe BPD or mortality [ Time Frame: corrected gestational age ] [ Designated as safety issue: No ]
    At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality


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

Estimated Enrollment: 72
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717625

Locations
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
Investigators
Study Chair: Moonsung Park, professor Ajou University
  More Information

No publications provided

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
Study First Received: October 26, 2012
Last Updated: October 29, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
montelukast
BPD
singulair
prematurity

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Premature Birth
Hyperplasia
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
Pathologic Processes
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013