Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Wang score after 72 hours of treatment
研究概览
简要总结
Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.
详细描述
In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.
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
- 1 Minute 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
- •Winter epidemic period from November, the 15th, to March the 15th
- •Age < 12 months
- •Admission Wang score included between 4 and 8
- •Infant hospitalized for gravity clinical criteria of severity
- •Nebulized 3 % hypertonic saline treatment since less than 24 hours
- •Infant with social security card coverage
- •Free consent of at least one of the parental authority holder
排除标准
- •Pulmonary, cardiac or neurologic chronic underlying disease
- •Prematurity < 32 GW
- •Asthma (3rd episode or more)
- •Admission oxygen saturation level < 85 %, Wang score ≥ 9
研究组 & 干预措施
Test group
3 % hypertonic saline up to 72H.
干预措施: 3 % hypertonic saline up to 72H (Drug)
Placebo control group
- 3 % hypertonic saline up to 24H.
- Followed by 48 hours of placebo (nebulized 0.9% normal saline).
干预措施: 3 % hypertonic saline up to 24H (Drug)
结局指标
主要结局
Wang score after 72 hours of treatment
时间窗: 72 hours
次要结局
- To assess average time of Oxygen therapy(From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))
- To determine variation of Wang score during hospitalisation(measured at Day 1, 2, 3, 4 and day of discharge.)
- To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation(From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))
- Recovery time(From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital))
- To assess average time of Tube feeding(From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))
- To determine percentage of patient with Adverse Event(From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))