NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Lancet Child Adolesc Health. 2022 Mar;6(3):150-157. doi: 10.1016/S2352-4642(21)00373-4. Epub 2021 Dec 8.
Very preterm infants are at increased risk of adverse outcomes in early childhood. We assessed whether delayed clamping of the umbilical cord reduces mortality or major disability at 2 years in the APTS Childhood Follow Up Study.
In this long-term follow-up analysis of the multicentre, randomised APTS trial in 25 centres in seven countries, infants (<30 weeks gestation) were randomly assigned before birth (1:1) to have clinicians aim to delay clamping for 60 s or more or clamp within 10 s of birth, both without cord milking. The primary outcome was death or major disability (cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay) at 2 years corrected age, analysed in the intention-to-treat population. This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12610000633088).
Between Oct 21, 2009, and Jan 6, 2017, consent was obtained for follow-up for 1531 infants, of whom 767 were randomly assigned to delayed clamping and 764 to immediate clamping. 384 (25%) of 1531 infants were multiple births, 862 (56%) infants were male, and 505 (33%) were born before 27 weeks gestation. 564 (74%) of 767 infants assigned to delayed clamping and 726 (96%) of 764 infants assigned to immediate clamping received treatment that fully adhered to the protocol. Death or major disability was determined in 1419 (93%) infants and occurred in 204 (29%) of 709 infants who were assigned to delayed clamping versus 240 (34%) of 710 assigned to immediate clamping, (relative risk [RR]) 0·83, 95% CI 0·72-0·95; p=0·010). 60 (8%) of 725 infants in the delayed clamping group and 81 (11%) of 720 infants in the immediate clamping group died by 2 years of age (RR 0·70, 95% CI 0·52-0·95); among those who survived, major disability at 2 years occurred in 23% (144/627) versus 26% (159/603) of infants, respectively (RR 0·88, 0·74-1·04).
Clamping the umbilical cord at least 60 s after birth reduced the risk of death or major disability at 2 years by 17%, reflecting a 30% reduction in relative mortality with no difference in major disability.
Australian National Health and Medical Research Council.
极早产儿在幼儿期有更高的不良结局风险。我们评估了在 APTS 儿童随访研究中，脐带延迟夹闭是否能降低 2 岁时的死亡率或主要残疾。
在这项来自 7 个国家 25 个中心的多中心、随机 APTS 试验的长期随访分析中，在出生前（1:1）将<30 周胎龄的婴儿随机分配到临床医生的目标是延迟夹闭 60 秒或更长时间，或在出生后 10 秒内夹闭，但都不进行脐带挤奶。主要结局是在 2 年校正年龄时死亡或主要残疾（脑瘫、严重视力丧失、需要助听器或耳蜗植入的耳聋、主要语言或言语问题或认知延迟），在意向治疗人群中进行分析。这项试验在澳大利亚和新西兰临床试验注册中心（ACTRN12610000633088）注册。
在 2009 年 10 月 21 日至 2017 年 1 月 6 日期间，获得了 1531 名婴儿的随访同意，其中 767 名被随机分配到延迟夹闭组，764 名分配到即刻夹闭组。1531 名婴儿中有 384 名（25%）为多胎妊娠，862 名（56%）为男性，505 名（33%）出生于 27 周前。767 名被分配到延迟夹闭组的婴儿中有 564 名（74%）和 764 名被分配到即刻夹闭组的婴儿中有 726 名（96%）接受了完全符合方案的治疗。在 1419 名（93%）婴儿中确定了死亡或主要残疾，在 709 名被分配到延迟夹闭组的婴儿中有 204 名（29%）和在 710 名被分配到即刻夹闭组的婴儿中有 240 名（34%）发生了死亡或主要残疾（相对风险 [RR]）0·83，95%CI 0·72-0·95；p=0·010）。在延迟夹闭组的 725 名婴儿中有 60 名（8%）和在即刻夹闭组的 720 名婴儿中有 81 名（11%）在 2 岁时死亡（RR 0·70，95%CI 0·52-0·95）；在存活的婴儿中，2 岁时发生主要残疾的分别为 23%（144/627）和 26%（159/603）（RR 0·88，0·74-1·04）。
在出生后至少 60 秒夹闭脐带可降低 2 岁时的死亡或主要残疾风险 17%，反映出相对死亡率降低了 30%，但主要残疾没有差异。
澳大利亚国家卫生与医学研究理事会。
