Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- length of hospital stay
研究概览
简要总结
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
详细描述
Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.
Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.
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
- None
入排标准
- 年龄范围
- 6 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between ages 6 weeks to 24 months
- •first episode of wheezing
- •diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score
排除标准
- •Children with mild bronchiolitis (Wang score < 5)
- •Children with pre-existent cardiac disease
- •Children with clinically significant chronic respiratory disease
- •Immunocompromised children
- •Children with a gestational age at birth less than 34 weeks
- •Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
- •Children who received corticosteroid in any form in the preceding 2 weeks before presentation
- •Children who received bronchodilators within 24 hours before presentation
- •Children with critical illness at presentation requiring immediate admission to intensive care unit
研究组 & 干预措施
NaCl 3% inhalations + standard therapy
In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy.
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed.
干预措施: NaCl 3% (Drug)
NaCl 3% inhalations + standard therapy
In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy.
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed.
干预措施: Standard therapy (Other)
Standard therapy
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
干预措施: Standard therapy (Other)
结局指标
主要结局
length of hospital stay
时间窗: 2 years
The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.
次要结局
- transfer rate to ICU(2 years)
- adverse events(2 years)
- Patients' ability to feed(2 years)
- Wang clinical severity score evolution(2 years)
- readmission rate in the next 7 days following discharge(2 years)
研究者
Raphaelle Jaquet-Pilloud
Jean-Yves Pauchard, MD
Hôpital de L'Enfance