Newborn Services, The Royal Women’s Hospital, Melbourne, Australia.
Pediatrics. 2013 Aug;132(2):e381-8. doi: 10.1542/peds.2013-0361. Epub 2013 Jul 29.
Positive-pressure ventilation (PPV) using a manual ventilation device and a face mask is recommended for compromised newborn infants in the delivery room (DR). Mask ventilation is associated with airway obstruction and leak. A nasal tube is an alternative interface, but its safety and efficacy have not been tested in extremely preterm infants.
An unblinded randomized controlled trial was conducted in Australia, and the Netherlands. Infants were stratified by gestational age (24-25/26-29 weeks) and center. Immediately before birth infants were randomly assigned to receive PPV and/or continuous positive airway pressure with either a nasal tube or a size 00 soft, round silicone mask. Resuscitation protocols were standardized; respiratory support was provided using a T-piece device commencing in room air. Criteria for intubation included need for cardiac compressions, apnea, continuous positive airway pressure >7 cm H2O, and fraction of inspired oxygen >0.4. Primary outcome was endotracheal intubation in the first 24 hours from birth.
Three hundred sixty-three infants were randomly assigned; the study terminated early on the grounds of futility. Baseline variables were similar between groups. Intubation rates in the first 24 hours were 54% and 55% in the nasal tube and face mask groups, respectively (odds ratio: 0.97; 95% confidence interval: 0.63-1.50). There were no important differences in any of the secondary outcomes within the whole cohort or between the 2 gestational age subgroups.
In infants at <30 weeks' gestation receiving PPV in the DR, there were no differences in short-term outcomes using the nasal tube compared with the face mask.
推荐在产房(DR)使用手动通气设备和面罩对有问题的新生儿进行正压通气(PPV)。面罩通气与气道阻塞和泄漏有关。鼻管是一种替代接口,但尚未在极早产儿中测试其安全性和有效性。
在澳大利亚和荷兰进行了一项非盲随机对照试验。根据胎龄(24-25/26-29 周)和中心对婴儿进行分层。在出生前,婴儿被随机分配接受 PPV 和/或连续气道正压通气,使用鼻管或 00 号软圆形硅胶面罩。复苏方案标准化;使用 T 型装置在空气开始时提供呼吸支持。插管标准包括需要心脏按压、呼吸暂停、持续气道正压>7 cm H2O 和吸入氧分数>0.4。主要结局是出生后 24 小时内气管内插管。
363 名婴儿被随机分配;由于无效,研究提前终止。组间基线变量相似。前 24 小时内的插管率分别为鼻管组和面罩组 54%和 55%(优势比:0.97;95%置信区间:0.63-1.50)。整个队列或两个胎龄亚组内的任何次要结局均无重要差异。
在接受 DR 中 PPV 的<30 周龄婴儿中,与面罩相比,鼻管在短期结局方面没有差异。