The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
NCT ID: NCT01717625
Last Updated: 2015-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2011-11-30
2013-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Montelukast
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
Control
Standard treatment of BPD and preterm infants
No interventions assigned to this group
Interventions
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Montelukast
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* cardiovascular collapse
* investigator's opinion
2 Weeks
10 Weeks
ALL
No
Sponsors
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Severance Hospital
OTHER
Seoul National University Hospital
OTHER
Gangnam Severance Hospital
OTHER
Korea University
OTHER
Ajou University School of Medicine
OTHER
Responsible Party
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Lee Janghoon
Assistant professor
Principal Investigators
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Moonsung Park, professor
Role: STUDY_CHAIR
Ajou University Medical Center
Locations
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Ajou university medical center
Suwon, Woncheon-dong, Yeongtong-gu,, South Korea
Countries
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Other Identifiers
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AJIRB-MED-CT2-11-242
Identifier Type: -
Identifier Source: org_study_id
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