经鼻高流量治疗用于早产儿的初级呼吸支持

Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants.

作者信息

Roberts Calum T, Owen Louise S, Manley Brett J, Frøisland Dag H, Donath Susan M, Dalziel Kim M, Pritchard Margo A, Cartwright David W, Collins Clare L, Malhotra Atul, Davis Peter G

机构信息

From Neonatal Services and Newborn Research Centre, Royal Women's Hospital (C.T.R., L.S.O., B.J.M., D.H.F., P.G.D.), the Departments of Obstetrics and Gynaecology (C.T.R., L.S.O., B.J.M., P.G.D.) and Paediatrics (S.M.D.) and School of Population and Global Health (K.M.D.), University of Melbourne, Critical Care and Neurosciences (L.S.O., P.G.D.) and Clinical Epidemiology and Biostatistics Unit (S.M.D.), Murdoch Children's Research Institute, Neonatal Services, Mercy Hospital for Women (C.L.C.), and Monash Newborn, Monash Children's Hospital, and Department of Paediatrics, Monash University (A.M.), Melbourne, VIC, and the School of Nursing, Midwifery and Paramedicine, Australian Catholic University (M.A.P.), Mater Research Institute (M.A.P.) and the Department of Paediatrics (D.W.C.), University of Queensland, and Women's and Newborn Services, Royal Brisbane and Women's Hospital (D.W.C.), Brisbane, QLD - all in Australia; and the Department of Pediatrics, Innlandet Hospital Trust, Lillehammer, Norway (D.H.F.).

出版信息

N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694.

DOI:10.1056/NEJMoa1603694

PMID:27653564

Abstract

BACKGROUND

Treatment with nasal high-flow therapy has efficacy similar to that of nasal continuous positive airway pressure (CPAP) when used as postextubation support in neonates. The efficacy of high-flow therapy as the primary means of respiratory support for preterm infants with respiratory distress has not been proved.

METHODS

In this international, multicenter, randomized, noninferiority trial, we assigned 564 preterm infants (gestational age, ≥28 weeks 0 days) with early respiratory distress who had not received surfactant replacement to treatment with either nasal high-flow therapy or nasal CPAP. The primary outcome was treatment failure within 72 hours after randomization. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the chosen margin of noninferiority was 10 percentage points. Infants in whom high-flow therapy failed could receive rescue CPAP; infants in whom CPAP failed were intubated and mechanically ventilated.

RESULTS

Trial recruitment stopped early at the recommendation of the independent data and safety monitoring committee because of a significant difference in the primary outcome between treatment groups. Treatment failure occurred in 71 of 278 infants (25.5%) in the high-flow group and in 38 of 286 infants (13.3%) in the CPAP group (risk difference, 12.3 percentage points; 95% confidence interval [CI], 5.8 to 18.7; P<0.001). The rate of intubation within 72 hours did not differ significantly between the high-flow and CPAP groups (15.5% and 11.5%, respectively; risk difference, 3.9 percentage points; 95% CI, -1.7 to 9.6; P=0.17), nor did the rate of adverse events.

CONCLUSIONS

When used as primary support for preterm infants with respiratory distress, high-flow therapy resulted in a significantly higher rate of treatment failure than did CPAP. (Funded by the National Health and Medical Research Council and others; Australian New Zealand Clinical Trials Registry number, ACTRN12613000303741 .).

摘要

背景

在新生儿拔管后支持治疗中，鼻高流量治疗的疗效与鼻持续气道正压通气（CPAP）相似。高流量治疗作为呼吸窘迫早产儿主要呼吸支持手段的疗效尚未得到证实。

方法

在这项国际多中心随机非劣效性试验中，我们将564例未接受表面活性剂替代治疗的早期呼吸窘迫早产儿（胎龄≥28周0天）随机分为鼻高流量治疗组或鼻CPAP治疗组。主要结局是随机分组后72小时内的治疗失败。通过计算主要结局风险的绝对差异来确定非劣效性；选定的非劣效性界值为10个百分点。高流量治疗失败的婴儿可接受挽救性CPAP治疗；CPAP治疗失败的婴儿进行气管插管并机械通气。

结果

根据独立数据与安全监测委员会的建议，试验提前终止，因为治疗组之间的主要结局存在显著差异。高流量组278例婴儿中有71例（25.5%）治疗失败，CPAP组286例婴儿中有38例（13.3%）治疗失败（风险差异为12.3个百分点；95%置信区间[CI]为5.8至18.7；P<0.001）。高流量组和CPAP组72小时内的插管率无显著差异（分别为15.5%和11.5%；风险差异为3.9个百分点；95%CI为-1.7至9.6；P=0.17），不良事件发生率也无显著差异。