The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe BPD or mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •congenital anomaly
- •cardiovascular collapse
- •investigator's opinion
研究组 & 干预措施
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
干预措施: Montelukast (Drug)
结局指标
主要结局
Incidence of moderate to severe BPD or mortality
时间窗: corrected gestational age
At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality
次要结局
- Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event(1, 2, 4 weeks since starting study)
研究者
Lee Janghoon
Assistant professor
Ajou University School of Medicine