TY - JOUR
T1 - Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at 2 years corrected age among very preterm infants (APTS)
T2 - a multicentre, randomised clinical trial
AU - Robledo, Kristy P.
AU - Tarnow-Mordi, William O.
AU - Rieger, Ingrid
AU - Suresh, Preeti
AU - Martin, Andrew
AU - Yeung, Carbo
AU - Ghadge, Alpana
AU - Liley, Helen G.
AU - Osborn, David
AU - Morris, Jonathan
AU - Hague, Wendy
AU - Kluckow, Martin
AU - Lui, Kei
AU - Soll, Roger
AU - Cruz, Melinda
AU - Keech, Anthony
AU - Kirby, Adrienne
AU - Simes, John
AU - APTS Childhood Follow-up Study collaborators
AU - Popat, Himanshu
AU - Reid, Shelley
AU - Gordon, Adrienne
AU - De Waal, Koert
AU - Wright, Ian M.
AU - Wright, Anne
AU - Buchan, Jane
AU - Stubbs, Michelle
AU - Newnham, John
AU - Simmer, Karen
AU - Young, Cherry
AU - Loh, Diane
AU - Kok, Yen
AU - Gill, Andy
AU - Strunk, Tobias
AU - Jeffery, Michele
AU - Chen, Yan
AU - Morris, Scott
AU - Sinhal, Sanjay
AU - Cornthwaite, Kathryn
AU - Walker, Sue P.
AU - Watkins, Andrew M.
AU - Collins, Clare L.
AU - Holberton, James R.
AU - Noble, Elizabeth J.
AU - Sehgal, Arvind
AU - Yeomans, Emma
AU - Elsayed, Kristy
AU - Mohamed, Abdel-Latif
AU - Broom, Margaret
AU - Koh, Guan
AU - Lawrence, Annemarie
AU - Gardener, Glen
AU - Fox, Jane
AU - Cartwright, David W.
AU - Koorts, Pieter
AU - Pritchard, Margo A.
AU - McKeown, Lisa
AU - Lainchbury, Anne
AU - Shand, Antonia W.
AU - Michalowski, Joanna
AU - Smyth, John P.
AU - Bolisetty, Srinivas
AU - Adno, Alan
AU - Lee, Gaksoo
AU - Seidler, Anna L.
AU - Askie, Lisa M.
AU - Groom, Katie M.
AU - Eaglen, Deborah A.
AU - Baker, Ella C.
AU - Patel, Harshad
AU - Wilkes, Natalie
AU - Gullam, Joanna E.
AU - Austin, Nicola
AU - Leishman, Dianne E.
AU - Weston, Phil
AU - White, Nicola
AU - Cooper, Nadia A.
AU - Broadbent, Roland
AU - Stitely, Michael
AU - Dawson, Pauline
AU - El-Naggar, Walid
AU - Furlong, Marlene
AU - Hatfield, Tara
AU - de Luca, Daniele
AU - Benachi, Alexandra
AU - Letamendia-Richard, Emmanuelle
AU - Escourrou, Guillaume
AU - Dell'Orto, Valentina
AU - Sweet, David
AU - Millar, Muriel
AU - Shah, Shilpa
AU - Sheikh, Lumaan
AU - Ariff, Shabina
AU - Morris, Erin A.
AU - Young, Leslie
AU - Evans, Shannon K.
AU - Belfort, Michael
AU - Aagaard, Kjersti
AU - Pammi, Mohan
AU - Mandy, George
AU - Gandhi, Manisha
AU - Davey, Jane
AU - Shenton, Emma
AU - Middleton, Jennifer
AU - Black, Roslyn
AU - Cheng, Annie
AU - Murdoch, Jamie
AU - Jacobs, Claire
AU - Meyer, Lizzie
AU - Medlin, Kathryn
AU - Woods, Heather
AU - O'Connor, Kerry-Ann
AU - Bice, Caitlin
AU - Scott, Katherine
AU - Hayes, Marie
AU - Cruickshank, Debbie
AU - Sam, Mekha
AU - Ireland, Susan
AU - Dickinson, Corrine
AU - Poulsen, Leith
AU - Fucek, Andreja
AU - Hegarty, Jo
AU - Rogers, Jenny
AU - Sanchez, Dorothy
AU - Zupan Simunek, Veronique
AU - Hanif, Bakhtawar
AU - Pahl, Adrienne
AU - Metayer, Jerilyn
AU - Duley, Lelia
AU - Marlow, Neil
AU - Schofield, Deborah
AU - Bowen, Jennifer
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85122929471&partnerID=8YFLogxK
U2 - 10.1016/S2352-4642(21)00373-4
DO - 10.1016/S2352-4642(21)00373-4
M3 - Article
C2 - 34895510
AN - SCOPUS:85122929471
SN - 2352-4642
VL - 6
SP - 150
EP - 157
JO - The Lancet Child and Adolescent Health
JF - The Lancet Child and Adolescent Health
IS - 3
ER -