Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at corrected age of 2 years in very preterm infants (APTS): a multicenter randomized clinical trial
Very premature infants are at increased risk for adverse outcomes in early childhood. We assessed whether late umbilical cord clamping reduced mortality or major disability at 2 years in the APTS Childhood Follow Up Study.
In this long-term follow-up analysis of the multicenter, randomized APTS trial at 25 centers in seven countries, infants (
Between October 21, 2009 and January 6, 2017, consent was obtained for the follow-up of 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 followed 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 before the age of 2 years (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).
Umbilical cord clamping 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.
Australian National Council for Health and Medical Research.