Study terminated early due to higher rate of severe intraventricular hemorrhage for umbilical cord milking
TUESDAY, Nov. 19, 2019 (HealthDay News) — In preterm infants born at less than 32 weeks of gestation, there is no significant difference in the rate for the composite outcome of mortality or severe intraventricular hemorrhage with umbilical cord milking versus delayed umbilical cord clamping, according to a study published in the Nov. 19 issue of the Journal of the American Medical Association, and the study was terminated early due to a significantly higher rate of severe intraventricular hemorrhage in the umbilical cord-milking group.
Anup Katheria, M.D., from the Sharp Mary Birch Hospital for Women & Newborns in San Diego, and colleagues enrolled 474 of a planned 1,500 infants born at less than 32 weeks of gestation in a randomized clinical trial that was terminated early. Infants were randomly assigned to receive either placental transfusion with umbilical cord milking or delayed cord clamping. Due to early termination of the trial, the planned noninferiority analysis could not be performed, and post-hoc comparison was conducted instead.
The researchers found that the composite primary outcome of death or severe intraventricular hemorrhage did not differ significantly for the umbilical cord-milking group versus the delayed cord-clamping group (12 versus 8 percent). However, the umbilical cord-milking group had a significantly increased rate of severe intraventricular hemorrhage (8 versus 3 percent).
“Although it’s not possible to draw definitive conclusions, the results suggest extreme caution in performing cord milking in this vulnerable group of infants,” Caroline Signore, M.D., from the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Rockville, Maryland, who oversaw the study, said in a statement.
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