NCT01370187已完成不适用
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Respiratory Distress Severity Score (RDSS)
研究概览
简要总结
The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.
详细描述
All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infant in 3-12 months of age with first episode of wheezing or bronchiolitis
- •written informed consent by parents
排除标准
- •Previous wheezing episode or confirmed asthma or bronchiolitis
- •recent bronchodilator use
- •immune deficient
- •immunosuppressive drug use
- •croup or pneumonia diagnosis
- •loss of follow up
研究组 & 干预措施
Montelukast
Experimental
4mg Montelukast daily for 2 months
干预措施: Montelukast (Drug)
结局指标
主要结局
Respiratory Distress Severity Score (RDSS)
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 days
RDSS is measured by wheezing (0, 1, 2)+ Cough (0, 1, 2)+Retraction (0, 1,2)+Respiratory rate(0,1,2)+ Oxygen saturation(0,1,2) scores
次要结局
- average number of cough daily= as expressed parents during visits(6 months)
- Wheezing severity in the physical examination by physician(6 Months)
研究者
研究点 (1)
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