Oei Ju Lee, Saugstad Ola D, Lui Kei, Wright Ian M, Smyth John P, Craven Paul, Wang Yueping Alex, McMullan Rowena, Coates Elisabeth, Ward Meredith, Mishra Parag, De Waal Koert, Travadi Javeed, See Kwee Ching, Cheah Irene G S, Lim Chin Theam, Choo Yao Mun, Kamar Azanna Ahmad, Cheah Fook Choe, Masoud Ahmed, Tarnow-Mordi William
School of Women's and Children's Health, the University of New South Wales, Australia;
Department of Newborn Care, Royal Hospital for Women, Australia.
Pediatrics. 2017 Jan;139(1). doi: 10.1542/peds.2016-1452.
Lower concentrations of oxygen (O) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O on the combined risk of death and disability at 2 years in infants <32 weeks' gestation.
A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.
Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13).
Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.
建议在早产儿复苏时采用较低浓度的氧气（O）（≤30%），以避免氧化损伤和脑缺血。其对长期预后的影响尚不确定。我们旨在确定使用空气（RA）或100%氧气对孕周<32周婴儿2岁时死亡和残疾综合风险的影响。
一项随机、非盲研究，旨在确定孕周<32周的婴儿在产房复苏开始时使用RA或100%氧气，并在5分钟时将脉搏血氧饱和度调整至65%至95%，直至新生儿重症监护病房（NICU）入院，观察其2岁时的主要残疾和死亡情况。
在6291名符合条件的患者中，招募了292名，287名（平均孕周：28.9周）纳入分析（RA组：n = 144；100%氧气组：n = 143）。根据数据与安全监测委员会的建议，由于使用100%氧气失去了均衡性，招募于2014年6月停止。在非预先指定的分析中，孕周<28周接受RA复苏的婴儿医院死亡率更高（RA组：46名中的10名[22%]；高于接受100%氧气组：54名中的3名[6%]；风险比：3.9[95%置信区间：1.1 - 13.4]；P = 0.01）。呼吸衰竭是最常见的死亡原因（n = 13）。
在孕周<28周的婴儿中，使用RA开始复苏与死亡风险增加相关。本研究并非预先指定的分析，且样本量不足以可靠地验证这一事后假设。需要更多数据。
