High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of patients with treatment failure
研究概览
简要总结
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
详细描述
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation <92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to pediatric ward due to a presumed viral bronchiolitis
- •Need of oxygen therapy (oxygen saturation < 92%)
排除标准
- •Pertussis
- •Needs intubation or CPAP on admission
- •Severe congenital heart defect
- •Down's syndrome
结局指标
主要结局
Number of patients with treatment failure
时间窗: 720 hours
Treatment failure = need for change of respiratory support method
次要结局
- Oxygen saturation (%)(At 30 min, 60 min, 90 min, 4 hours, 8 hours)
- Number of participants needing admission to intensive care unit (ICU)(720 hours)
- Time from randomisation to end of oxygen therapy(At 30 min, 60 min, 90 min, 4 hours, 8 hours)
- Time from hospital admission to discharge (hours)(720 hours)
- Respiratory rate measured by the study physician/nurse(At 30 min, 60 min, 90 min, 4 hours, 8 hours)