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

Background
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.
Methods
In this long-term follow-up analysis of the multicenter, randomized APTS trial at 25 centers in seven countries, infants (
Results
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).
Interpretation
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.
Funding
Australian National Council for Health and Medical Research.