From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney (W.T.-M., A. Kirby, K.R., L.A., R.B., S.F., V.G., A. Ghadge, W.H., A. Keech, L. Sebastian, J.S.), University of Sydney (J.M., N.E., M.F., D.I., M.J., M.K., H. Popat, H.L., D.O.), Royal North Shore Hospital (Y.C.), and University of New South Wales (K.L.), Sydney, Australian National University, Canberra (M.A.-L., G.R.), University of Queensland, Brisbane (P.C., H.L., M. Pritchard), James Cook University, Cairns (G.K.), University of Western Australia, Perth (A. Gill, J.N., K.S.), Flinders University, Adelaide (S.M.), Monash University (A.S., E.W.) and University of Melbourne (S.W.), Melbourne, Mercy Hospital for Women, Heidelberg (A.W.), and University of Newcastle, Newcastle (K.W., P.F.), and University of Wollongong, Wollongong (I.W.) - all in Australia; Baylor College of Medicine, Houston (K.A., M.B., M. Pammi); Aga Khan University Hospital, Karachi, Pakistan (S.A., L. Sheikh); Hôpital Antoine-Beclere, Clamart, France (D.L.); University of Nottingham, Nottingham, United Kingdom (L.D.); Dalhousie University, Halifax, NS, Canada (W.E.-N.); University of Auckland, Auckland (K.G.), and University of Otago, Dunedin (P.W., J.G., H. Patel) - both in New Zealand; University College London, London (N.M.), and Royal Jubilee Maternity Hospital, Belfast (D.S.) - both in the United Kingdom; and University of Vermont, Burlington (R.S., L.Y.).
N Engl J Med. 2017 Dec 21;377(25):2445-2455. doi: 10.1056/NEJMoa1711281. Epub 2017 Oct 29.
The preferred timing of umbilical-cord clamping in preterm infants is unclear.
We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (≤10 seconds after delivery) or delayed clamping (≥60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births.
Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P=0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P=0.03 in unadjusted analyses; P=0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities.
Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping. (Funded by the Australian National Health and Medical Research Council [NHMRC] and the NHMRC Clinical Trials Centre; APTS Australian and New Zealand Clinical Trials Registry number, ACTRN12610000633088 .).
早产儿脐带夹闭的最佳时机仍不明确。
我们将预计在 30 孕周前分娩的孕妇所分娩的胎儿随机分为脐带即刻夹闭（分娩后 10 秒内）组或延迟夹闭（分娩后 60 秒后）组。主要复合结局为 36 孕周时的死亡或主要并发症（定义为出生后超声检查严重脑损伤、重度早产儿视网膜病变、坏死性小肠结肠炎或晚发性败血症）。分析基于意向治疗原则，考虑了多胎妊娠。
在 1634 例接受随机分组的胎儿中，有 1566 例在 30 孕周前存活分娩；其中 782 例被分至即刻夹闭组，784 例分至延迟夹闭组。两组脐带夹闭时间中位数分别为 5 秒和 60 秒。1497 例（95.6%）婴儿的主要结局数据完整。延迟夹闭组（37.0%）与即刻夹闭组（37.2%）的主要结局发生率无显著差异（相对风险，1.00；95%置信区间，0.88 至 1.13；P=0.96）。延迟夹闭组的死亡率为 6.4%，即刻夹闭组为 9.0%（未校正分析中 P=0.03；校正多个次要结局后 P=0.39）。两组慢性肺病或其他主要并发症的发生率无显著差异。
在早产儿中，与即刻夹闭相比，延迟夹闭并未降低 36 孕周时死亡或主要并发症的联合发生率。（由澳大利亚国家卫生与医学研究理事会[NHMRC]和 NHMRC 临床试验中心资助；APTS 澳大利亚和新西兰临床试验注册中心编号，ACTRN12610000633088。）
