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Randomized Controlled Trial Multicenter Study
Delayed versus Immediate Cord Clamping in Preterm Infants.
- William Tarnow-Mordi, Jonathan Morris, Adrienne Kirby, Kristy Robledo, Lisa Askie, Rebecca Brown, Nicholas Evans, Sarah Finlayson, Michael Fogarty, Val Gebski, Alpana Ghadge, Wendy Hague, David Isaacs, Mic... more
- 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.), Universi... more
- N. Engl. J. Med. 2017 Dec 21; 377 (25): 2445-2455.
BackgroundThe preferred timing of umbilical-cord clamping in preterm infants is unclear.MethodsWe 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.ResultsOf 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.ConclusionsAmong 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 .).
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