The safety and efficacy of bubble continuous positive airway pressure (bCPAP) for treatment of childhood severe pneumonia outside tertiary care hospitals is uncertain. We did a cluster-randomised effectiveness trial of locally made bCPAP compared with WHO-recommended low-flow oxygen therapy in children with severe pneumonia and hypoxaemia in general hospitals in Ethiopia. This open, cluster-randomised trial was done in 12 general (secondary) hospitals in Ethiopia. We randomly assigned six hospitals to bCPAP as first-line respiratory support for children aged 1–59 months who presented with severe pneumonia and hypoxaemia and six hospitals to standard low-flow oxygen therapy. Cluster (hospital) randomisation was stratified by availability of mechanical ventilation. All children received treatment in paediatric wards (in a dedicated corner in front of a nursing station) with a similar level of facilities (equipment for oxygen therapy and medications) and staffing (overall, one nurse per six patients and one general practitioner per 18 patients) in all hospitals. All children received additional care according to WHO guidelines, supervised by paediatricians and general practitioners. The primary outcome was treatment failure (defined as any of the following: peripheral oxygen saturation <85% at any time after at least 1 h of intervention plus signs of respiratory distress; indication for mechanical ventilation; death during hospital stay or within 72 h of leaving hospital against medical advice; or leaving hospital against medical advice during intervention). The analysis included all children enrolled in the trial. We performed both unadjusted and adjusted analyses of the primary outcome, with the latter adjusted for the stratification variable and for the design effect of cluster randomisation, as well as selected potentially confounding variables, including age. We calculated effectiveness as the relative risk (RR) of the outcomes in the bCPAP group versus low-flow oxygen group. This trial is registered with , , and is completed. From June 8, 2021, to July 27, 2022, 1240 children were enrolled (620 in hospitals allocated to bCPAP and 620 in hospitals allocated to low-flow oxygen). Cluster sizes ranged from 103 to 104 children. Five (0·8%) of 620 children in the bCPAP group had treatment failure compared with 21 (3·4%) of 620 children in the low-flow oxygen group (unadjusted RR 0·24, 95% CI 0·09–0·63, p=0·0015; adjusted RR 0·24, 0·07–0·87, p=0·030). Six children died during hospital stay, all of whom were in the low-flow oxygen group (p=0·031). No serious adverse events were attributable to bCPAP. In Ethiopian general hospitals, introduction of locally made bCPAP, supervised by general practitioners and paediatricians, was associated with reduced risk of treatment failure and in-hospital mortality in children with severe pneumonia and hypoxaemia compared with use of standard low-flow oxygen therapy. Implementation research is required in higher mortality settings to consolidate our findings. SIDA Sweden and Grand Challenges Ethiopia.

中文翻译：

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气泡持续气道正压通气治疗埃塞俄比亚1-59个月严重肺炎和低氧血症儿童的有效性：一项实用的整群随机对照试验


三级医院以外的气泡持续气道正压通气（bCPAP）治疗儿童重症肺炎的安全性和有效性尚不确定。我们对埃塞俄比亚综合医院患有严重肺炎和低氧血症的儿童进行了一项整群随机有效性试验，将当地生产的 bCPAP 与世界卫生组织推荐的低流量氧疗进行比较。这项开放、整群随机试验在埃塞俄比亚 12 家综合（二级）医院进行。我们随机分配 6 家医院接受 bCPAP 作为 1-59 个月大的患有严重肺炎和低氧血症儿童的一线呼吸支持，并随机分配 6 家医院接受标准低流量氧疗。集群（医院）随机化根据机械通气的可用性进行分层。所有儿童都在儿科病房（护理站前的专用角落）接受治疗，病房的设施水平（氧疗和药物设备）和人员配备水平相似（总体而言，每 6 名患者配备 1 名护士，每 18 名患者配备 1 名全科医生） ）在所有医院。根据世界卫生组织的指导方针，所有儿童都在儿科医生和全科医生的监督下接受了额外的护理。主要结局是治疗失败（定义为以下任一情况：干预至少 1 小时后任何时间外周血氧饱和度 <85%，加上呼吸窘迫体征；机械通气指征；住院期间或干预后 72 小时内死亡不顾医疗建议离开医院；或在干预期间不顾医疗建议离开医院）。该分析包括所有参加试验的儿童。 我们对主要结果进行了未经调整和调整的分析，后者针对分层变量和整群随机化的设计效果以及选定的潜在混杂变量（包括年龄）进行了调整。我们将有效性计算为 bCPAP 组与低流量吸氧组结果的相对风险 (RR)。该试验已在 、 、 注册，并已完成。从 2021 年 6 月 8 日到 2022 年 7 月 27 日，共有 1240 名儿童入组（其中 620 名儿童在分配给 bCPAP 的医院中，620 名在分配给低流量氧气的医院中）。集群大小从 103 到 104 个儿童不等。 bCPAP 组 620 名儿童中有 5 名 (0·8%) 治疗失败，而低流量吸氧组 620 名儿童中有 21 名 (3·4%) 治疗失败（未调整 RR 0·24，95% CI 0·09– 0·63，p=0·0015；调整后的 RR 0·24，0·07–0·87，p=0·030）。六名儿童在住院期间死亡，他们均属于低流量吸氧组（p=0·031）。没有因 bCPAP 引起的严重不良事件。在埃塞俄比亚综合医院，与使用标准低流量氧疗相比，在全科医生和儿科医生的监督下采用本地制造的 bCPAP 可以降低患有严重肺炎和低氧血症的儿童的治疗失败和院内死亡率。需要在死亡率较高的环境中进行实施研究以巩固我们的研究结果。瑞典 SIDA 和埃塞俄比亚重大挑战。