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, H.
AU - Reid, S.
AU - De Waal, K.
AU - Wright, I.
AU - Wright, A.
AU - Buchan, J.
AU - Stubbs, M.
AU - Newnham, J.
AU - Simmer, K.
AU - Young, C.
AU - Loh, D.
AU - Kok, Y.
AU - Gill, A.
AU - Jeffery, M.
AU - Chen, Y.
AU - Morris, S.
AU - Sinhal, S.
AU - Cornthwaite, K.
AU - Walker, S.
AU - Watkins, A.
AU - Collins, C.
AU - Holberton, J.
AU - Noble, E.
AU - Sehgal, A.
AU - Yeomans, E.
AU - Elsayed, K.
AU - Mohamed, A. L.
AU - Broom, M.
AU - Koh, G.
AU - Lawrence, A.
AU - Gardener, G.
AU - Fox, J.
AU - Cartwright, D.
AU - Koorts, P.
AU - Pritchard, M.
AU - McKeown, L.
AU - Lainchbury, A.
AU - Shand, A.
AU - Michalowski, J.
AU - Smyth, J.
AU - Bolisetty, S.
AU - Adno, A.
AU - Lee, G.
AU - Seidler, Anna Lene
AU - Askie, Lisa
AU - Groom, K.
AU - Eaglen, D.
AU - Baker, E.
AU - Patel, H.
AU - Wilkes, N.
AU - Gullam, J.
AU - Austin, N.
AU - Leishman, D.
AU - Weston, P.
AU - White, N.
AU - Cooper, N.
AU - Broadbent, R.
AU - Stitely, M.
AU - Dawson, P.
AU - El-Naggar, W.
AU - Furlong, M.
AU - de Luca, D.
AU - Benachi, A.
AU - Letamendia, E.
AU - Escourrou, G.
AU - Dell'Orto, V.
AU - Sweet, D.
AU - Millar, M.
AU - Eltayeb, M.
AU - Sheikh, L.
AU - Ariff, S.
AU - Morris, E.
AU - Young, L.
AU - Evans, S.
AU - Belfort, M.
AU - Aagaard, K.
AU - Pammi, M.
AU - Mandy, G.
AU - Gandhi, M.
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.
KW - Preterm infants
KW - umbilical cord
KW - Infant mortality
KW - disability
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 -