The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia (BPD)
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.
Infant, Very Low Birth Weight
|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|
- 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
- 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 ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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
|Korea, Republic of|
|Ajou university medical center|
|Suwon, Woncheon-dong, Yeongtong-gu,, Korea, Republic of, 443-721|
|Study Chair:||Moonsung Park, professor||Ajou University|