Manley Brett J, Roberts Calum T, Arnolda Gaston R B, Wright Ian M R, Owen Louise S, Dalziel Kim M, Foster Jann P, Davis Peter G, Buckmaster Adam G
Neonatal Services and Newborn Research Centre, The Royal Women's Hospital, Parkville, Victoria, Australia.
Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, Australia.
BMJ Open. 2017 Jun 23;7(6):e016746. doi: 10.1136/bmjopen-2017-016746.
Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs.
The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are <24 hours old at randomisation and require non-invasive respiratory support or supplemental oxygen for >1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload.
Multisite ethical approval for the study has been granted by The Royal Children's Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences.
Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results.
经鼻高流量（nHF）治疗是新生儿常用的呼吸支持模式。nHF使用的证据主要来自新生儿重症监护病房（NICU）。在非三级特殊护理病房（SCN）中，尚无关于nHF使用的随机试验。我们假设，在非三级SCN护理的人群中，nHF作为呼吸窘迫新生儿的主要支持手段，不劣于经鼻持续气道正压通气（CPAP）。
HUNTER试验是一项开放的澳大利亚多中心随机非劣效性试验。孕龄≥31周、出生体重≥1200g且入住参与研究的非三级SCN的婴儿符合入选条件，随机分组时年龄<24小时，且需要无创呼吸支持或补充氧气超过1小时。婴儿被随机分为接受nHF或CPAP治疗。主要结局是随机分组后72小时内的治疗失败，根据客观氧合、呼吸暂停或血气标准，或根据需要紧急插管和机械通气或转至三级NICU的临床决定来确定。次要结局包括需要引流的气胸发生率、呼吸支持持续时间、补充氧气和住院时间、与住院护理相关的费用、成本效益、父母压力和满意度以及护理工作量。
该研究已获得澳大利亚墨尔本皇家儿童医院（试验参考编号34222）以及每个参与研究地点的多中心伦理批准。该试验目前正在澳大利亚维多利亚州和新南威尔士州的八个中心招募患者，之前的一个地点已停止招募。试验结果将发表在同行评审期刊上，并将在国内和国际会议上展示。
澳大利亚和新西兰临床试验注册中心（ANZCTR）：ACTRN12614001203640；预结果。
