Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- respiratory clinical score
研究概览
简要总结
Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.
详细描述
Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers.
Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.
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
- 0 Years 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under one year of age
- •first episode of wheezing and dyspnea
- •RSV antigen detected by ELISA
- •parents signed informed consent.
排除标准
- •infants with chronic lung disease
- •cardiac disease
- •other chronic conditions.
结局指标
主要结局
respiratory clinical score
computerized quantification of wheezing and crackles
次要结局
未报告次要终点