NCT00213226已完成3 期
Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
研究概览
简要总结
This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department
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
- 2 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants 2 to 24 months of age
- •acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
- •moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
- •only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized
排除标准
- •previous wheezing and/or bronchodilator therapy
- •hospitalization at 240 minutes
- •critically ill patients needing airway stabilization
- •patients with low or very high baseline disease severity (RDAI <5 and >16)
- •patients under 8 weeks of age
- •patients on corticosteroids prior to arrival at Emergency Department
- •contact with varicella within 21 days
- •past history of ventilation for greater than 24 hours
- •existing cardiopulmonary disease, multisystem disease or immunodeficiency
- •insufficient command of the English language
结局指标
主要结局
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
次要结局
- Respiratory Assessment Change Score (RACS) at 96 and 144 hours
- Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
- Proportion of infants with no signs of respiratory distress at 96 and 144 hours
- Proportion of infants who are symptomatic at 14 days
研究者
Suzanne Schuh
Staff Physician
The Hospital for Sick Children
研究点 (2)
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