Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at 2 years corrected age among very preterm infants (APTS): a multicentre, randomised clinical trial. (March 2022)

• Record Type: Journal Article
• Authors: Robledo, Kristy P; Tarnow-Mordi, William O; Rieger, Ingrid; Suresh, Preeti; Martin, Andrew; Yeung, Carbo; Ghadge, Alpana; Liley, Helen G; Osborn, David; Morris, Jonathan; Hague, Wendy; Kluckow, Martin; Lui, Kei; Soll, Roger; Cruz, Melinda; Keech, Anthony; Kirby, Adrienne; Simes, John; Popat, Himanshu; Reid, Shelley; Gordon, Adrienne; De Waal, Koert; Wright, Ian M; Wright, Anne; Buchan, Jane; Stubbs, Michelle; Newnham, John; Simmer, Karen; Young, Cherry; Loh, Diane; Kok, Yen; Gill, Andy; Strunk, Tobias; Jeffery, Michele; Chen, Yan; Morris, Scott; Sinhal, Sanjay; Cornthwaite, Kathryn; Walker, Sue P; Watkins, Andrew M; Collins, Clare L; Holberton, James R; Noble, Elizabeth J; Sehgal, Arvind; Yeomans, Emma; Elsayed, Kristy; Mohamed, Abdel-Latif; Broom, Margaret; Koh, Guan; Lawrence, Annemarie; Gardener, Glen; Fox, Jane; Cartwright, David W; Koorts, Pieter; Pritchard, Margo A; McKeown, Lisa; Lainchbury, Anne; Shand, Antonia W; Michalowski, Joanna; Smyth, John P; Bolisetty, Srinivas; Adno, Alan; Lee, Gaksoo; Seidler, Anna L; Askie, Lisa M; Groom, Katie M; Eaglen, Deborah A; Baker, Ella C; Patel, Harshad; Wilkes, Natalie; Gullam, Joanna E; Austin, Nicola; Leishman, Dianne E; Weston, Phil; White, Nicola; Cooper, Nadia A; Broadbent, Roland; Stitely, Michael; Dawson, Pauline; El-Naggar, Walid; Furlong, Marlene; Hatfield, Tara; de Luca, Daniele; Benachi, Alexandra; Letamendia-Richard, Emmanuelle; Escourrou, Guillaume; Dell'Orto, Valentina; Sweet, David; Millar, Muriel; Shah, Shilpa; Sheikh, Lumaan; Ariff, Shabina; Morris, Erin A; Young, Leslie; Evans, Shannon K; Belfort, Michael; Aagaard, Kjersti; Pammi, Mohan; Mandy, George; Gandhi, Manisha; Davey, Jane; Shenton, Emma; Middleton, Jennifer; Black, Roslyn; Cheng, Annie; Murdoch, Jamie; Jacobs, Claire; Meyer, Lizzie; Medlin, Kathryn; Woods, Heather; O'Connor, Kerry-Ann; Bice, Caitlin; Scott, Katherine; Hayes, Marie; Cruickshank, Debbie; Sam, Mekha; Ireland, Susan; Dickinson, Corrine; Poulsen, Leith; Fucek, Andreja; Hegarty, Jo; Rogers, Jenny; Sanchez, Dorothy; Zupan Simunek, Veronique; Hanif, Bakhtawar; Pahl, Adrienne; Metayer, Jerilyn; Duley, Lelia; Marlow, Neil; Schofield, Deborah; Bowen, Jennifer;
• Is Part Of: Lancet. Volume 6:Number 3(2022)
• Page Start: 150
• Page End: 157
• Publication Date: 2022-03
• Subjects: Pediatrics -- Periodicals; Children -- Health and hygiene -- Periodicals; Adolescent medicine -- Periodicals; Teenagers -- Health and hygiene -- Periodicals; 618.920005
• DOI: 10.1016/S2352-4642(21)00373-4
• Languages: English
• ISSNs: 2352-4642

Abstract

Summary: Background: 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. Methods: 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). Findings: 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). Interpretation: 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. Funding: Australian National Health and Medical Research Council.