The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia (BPD)
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|ClinicalTrials.gov Identifier: NCT01717625|
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : February 10, 2015
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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
- 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
- Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event [ Time Frame: 1, 2, 4 weeks since starting study ]
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|
|Study Chair:||Moonsung Park, professor||Ajou University Medical Center|