3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 778
- 试验地点
- 21
- 主要终点
- Admission rate
研究概览
简要总结
The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).
详细描述
Acute viral bronchiolitis remains a significant cause of hospitalization and to date, no treatment reduce the rate of hospitalization. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and for hospitalized hypoxemic infants, oxygen administration.
Several studies shown that nebulization of hypertonic saline solution reduce length of stay in hospital for hospitalized infant but effect on rate of hospitalization remains unclear.
The investigators propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 21 emergency departments of hospitals situated France, during 2 winter seasons.
The investigators hypothesize that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 24 hours after treatment compared to placebo.
Secondary objectives are to compare between groups intensity of respiratory symptoms measured by RDAI clinical score, duration of symptoms, length of hospital stay for hospitalized infants, adverse effects and health care utilization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 weeks through 12 months
- •First moderate to severe episode of acute viral bronchiolitis (history of viral upper respiratory tract infection plus wheezing and/or crackles on chest auscultation with respiratory distress ).
- •Admission in Emergency Department
- •Parental/guardian permission (informed consent)
排除标准
- •prematurity < 37 weeks
- •artificial ventilation in the neonatal period
- •Chronic lung or heart disease
- •history of immunodeficiency
- •past use of nebulized HS
- •initial need for intensive care of assisted ventilation
- •Non-French speaking parent/guardian
研究组 & 干预措施
3% Saline
Nebulized 3% Saline
干预措施: 3% Saline (Drug)
0.9% Normal Saline
Nebulized 0.9% normal saline
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
Admission rate
时间窗: 24 hours
次要结局
- change in RDAI score(2 hours)
- Number of Participants with Adverse Events(2 hours)
- length of hospitalization for hospitalized infant(1 month)
- health care utilisation(1 month)