NCT00230841已完成2 期
Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- changes in the croup score from baseline to 30 and 60 minutes
研究概览
简要总结
Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).
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
入排标准
- 年龄范围
- 3 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 3 months - 10 years
- •croup score greater than or equal to 2 after a 30 minute waiting period
排除标准
- •Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
- •symptoms or signs of alternative causes of stridor
- •inability of caregivers to understand or speak English and/or sign for informed consent
- •history of chronic pulmonary disease except for asthma, or co-existent systemic disease
- •previous history of intubation
- •duration of present illness >1 week
- •systemic or inhaled glucocorticoids in previous 48 hours
- •epinephrine in previous 4 hours
结局指标
主要结局
changes in the croup score from baseline to 30 and 60 minutes
次要结局
- discharge rate at 60 minutes
- steroid or epinephrine treatment at 60 minutes
- change in pulse, respiratory rate, and oxygen saturation at 60 minutes
研究者
Dennis Scolnik
Staff Physician
The Hospital for Sick Children
研究点 (2)
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