High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
研究概览
简要总结
Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis.
However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.
详细描述
Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions )
- •aged 7 days- 6 months
- •transcutaneous SpO2 in room air < 95%
- •modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5
- •agreement of at least one of the parents or legal tutor for his child to participate in biomedical research
- •affiliation to social security (beneficiary or entitled), except beneficiary of State medical help
排除标准
- •Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route
- •Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP)
- •Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy
- •Inclusion in other observational study.
研究组 & 干预措施
High-flow nasal canula oxygen therapy
High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher&Paykel (F&P), NZ)
干预措施: High-flow nasal canula oxygen therapy (Device)
Low-flow oxygen therapy
Low-flow oxygen therapy with standard nasal canula
干预措施: Low-flow oxygen therapy with standard nasal canula (Device)
结局指标
主要结局
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
时间窗: Up to an average of 7 days
Treatment failure is defined if one or more following criteria are met: refractory apnea (\> 3/h), oxygen requirement in HFN therapy arm exceeds fraction of inspired oxygen (FiO2) ≥ 40 % or oxygen requirement in standard nasal oxygen therapy arm exceeds \>2l/min to maintain oxygen saturation (SpO2) ≥94 %), m-WCAS score increased compared to admission at H6 and/or \> 5 , PaCO2 (H6 ) increased compared to admission and \> 60-70 mmHg.
次要结局
- Assessment of short term respiratory status(at the end of the follow up (an average of 7 days))
- Transfer to pediatrics intensive care unit (PICU)(at the end of the follow up (an average of 7 days))
- Length of stay in paediatric general ward unit(at the end of the follow up (an average of 7 days))
- Oxgen-support free days(at the end of the follow up (an average of 7 days))
- Artificial nutritional-support free days(at the end of the follow up (an average of 7 days))