Breathing Assistance in CHildren with bronchiolitis (BACHb): a group-sequential two-stratum multicentre open-label randomised clinical trial of respiratory support in infants with acute bronchiolitis

Imperial College London0 个研究点目标入组 1,508 人开始时间: 2023年9月4日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•1. Hospitalised infant aged < 12 months with a clinical diagnosis of acute bronchiolitis AND
•2. Clinically assessed at least twice 15 minutes apart to have EITHER:
•2.1. Severe respiratory distress (respiratory rate > 70/min, or grunting, or marked chest recession) and/or recurrent short apnoeas (> 3 per hour, each apnoea lasting < 10 sec) [SEVERE BRONCHIOLITIS stratum], OR
•2.2. Lack of response to LFNC oxygen up to 2 L/min, as indicated by persistent hypoxia (SpO2 < 90%, or < 92% if age < 6 weeks or if underlying health problems present) and/or moderate respiratory distress (respiratory rate 55-70/min and moderate chest recession) [MODERATE BRONCHIOLITIS stratum].

•1. Clinical decision that patient needs immediate intubation and ventilation for life-threatening hypoxia, shock or decreased conscious level.
•2. Prolonged apnoeas (> 10 seconds needing stimulation).
•3. Ongoing active air leak (pneumothorax, pneumomediastinum).
•4. Received HSO, HFNC or CPAP for over 2 hours in the previous 24 hours.
•5. On home ventilation prior to hospital admission.
•6. Tracheostomy in place.
•7. Choanal atresia/stenosis, midfacial anomalies or recent craniofacial surgery.
•8. Previously recruited to the BACHb trial.

发起方