Nasal High-Flow Therapy for Newborn Infants in Special Care Nurseries
Brett J. Manley, Gaston R.B. Arnolda, Ian M.R. Wright, et al
N Engl J Med 2019; 380:2031-2040
DOI: 10.1056/NEJMoa1812077
Abstract
BACKGROUND 背景
Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown.
作为新生儿呼吸支持治疗的一种方法，高流量鼻导管氧疗可以替代经鼻持续气道正压通气(CPAP)。高流量氧疗在非三级医疗机构的疗效未知。
METHODS 方法
We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points.
我们进行了一项多中心、随机、非劣效研究，纳入澳大利亚特护婴儿室的新生儿（出生< 24小时；孕周≥ 31周）。合并呼吸窘迫且出生体重至少1200 g的新生儿随机分组，分别接受高流量氧疗或CPAP。主要预后指标为随机分组后72小时内治疗失败。高流量氧疗失败者可接受CPAP。通过计算主要预后指标风险的绝对差异确定非劣效，非劣效边际确定为10个百分点。
RESULTS 结果
A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups.
共有754例新生儿（平均孕周36.9周，平均出生体重2909 g）纳入主要意向治疗分析。高流量组381例婴儿中78例(20.5%)及CPAP组373例婴儿中38例(10.2%)发生治疗失败（风险差异，10.3个百分点；95%可信区间[CI] 5.2 to 15.4）。在次要符合方案集分析中，高流量组339例婴儿中49例(14.5%)与CPAP组338例婴儿中28例(8.0%)发生治疗失败（绝对差异，6.5个百分点；95%CI，1.7 to 11.2）。两组间机械通气比例、转诊至三级新生儿ICU的比例以及不良事件发生率无显著差异。
CONCLUSIONS 结论
Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress. (Funded by the Australian National Health and Medical Research Council and Monash University; HUNTER Australian and New Zealand Clinical Trials Registry number, ACTRN12614001203640.)
用于非三级特护婴儿室中作为合并呼吸窘迫新生儿的早期呼吸支持治疗措施时，与CPAP相比，经鼻高流量氧疗并未显示出非劣效，且导致更高的治疗失败率。
