Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Successful hospital discharge at three days
研究概览
简要总结
The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).
Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.
- Nebulizer 1 (Treatment)
- Treatment + 30 minutes (approximately) Nebulizer 2
- Treatment + 60 minutes (approximately) Nebulizer 3
- Treatment + 120 minutes (approximately)
The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.
详细描述
Double blind RCT. Primary outcome measure is admission defined as actual admission or discharge with unscheduled return leading to admission within 72 hours. Secondary endpoints include change in severity of illness and response of respiratory parameters to treatment.
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
- Double
入排标准
- 年龄范围
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of bronchiolitis
排除标准
- •Age greater than 18 months
- •Disease too mild to warrant any treatment
- •Emergent intubation on arrival at the ED
- •Participation within another study within 30 days
- •Refusal of informed parental consent
结局指标
主要结局
Successful hospital discharge at three days
次要结局
- Improvement in severity of disease score
- Improvement in respiratory status