Law Brenda Hiu Yan, Asztalos Elizabeth, Finer Neil N, Yaskina Maryna, Vento Maximo, Tarnow-Mordi William, Shah Prakesh S, Schmölzer Georg M
Centre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Alberta Health Services, Edmonton, AB T5H 3V9, Canada.
Division of Neonatology, Department of Pediatrics, University of Alberta, Edmonton, AB T6G 2R3, Canada.
Children (Basel). 2021 Oct 20;8(11):942. doi: 10.3390/children8110942.
Optimal starting oxygen concentration for delivery room resuscitation of extremely preterm infants (<29 weeks) remains unknown, with recommendations of 21-30% based on uncertain evidence. Individual patient randomized trials designed to answer this question have been hampered by poor enrolment.
It is feasible to compare 30% vs. 60% starting oxygen for delivery room resuscitation of extremely preterm infants using a change in local hospital policy and deferred consent approach.
Prospective, single-center, feasibility study, with each starting oxygen concentration used for two months for all eligible infants.
Infants born at 23 + 0-28 + 6 weeks' gestation who received delivery room resuscitation. Study interventions: Initial oxygen at 30% or 60%, increasing by 10-20% every minute for heart rate < 100 bpm, or increase to 100% for chest compressions.
Feasibility, defined by (i) achieving difference in cumulative supplied oxygen concentration between groups, and (ii) post-intervention rate consent >50%.
Thirty-four infants were born during a 4-month period; consent was obtained in 63%. Thirty ( = 12, 30% group; = 18, 60% group) were analyzed, including limited data from eight who died or were transferred before parents could be approached. Median cumulative oxygen concentrations were significantly different between the two groups in the first 5 min.
Randomized control trial of 30% or 60% oxygen at the initiation of resuscitation of extremely preterm neonates with deferred consent is feasible.
Clinicaltrials.gov NCT03706586.
极早产儿（<29周）产房复苏的最佳起始氧浓度仍不明确，基于不确定的证据，推荐浓度为21%-30%。旨在回答这个问题的个体患者随机试验因入组不佳而受阻。
采用当地医院政策改变和延迟同意方法，比较极早产儿产房复苏起始氧浓度30%与60%是可行的。
前瞻性、单中心可行性研究，所有符合条件的婴儿每种起始氧浓度使用两个月。
孕23+0-28+6周出生且接受产房复苏的婴儿。研究干预措施：初始氧浓度为30%或60%，心率<100次/分时每分钟增加10%-20%，或进行胸外按压时增加至100%。
可行性，定义为（i）两组间累计供应氧浓度有差异，以及（ii）干预后同意率>50%。
在4个月期间有34名婴儿出生；63%获得了同意。分析了30名婴儿（30%组12名，60%组18名），包括8名在联系家长之前死亡或转诊婴儿的有限数据。两组在前5分钟的中位累计氧浓度有显著差异。
对极早早产儿复苏起始时采用30%或60%氧浓度并延迟同意的随机对照试验是可行的。
Clinicaltrials.gov NCT03706586
