Randomised trial of cord clamping at very preterm birth: outcomes at 2 years

摘要

Objective To report outcomes at 2 years corrected age for children of women recruited to a trial comparing alternative policies for timing of cord clamping and immediate neonatal care at very preterm birth. Design Parallel group randomised (1:1) trial. Setting Eight UK tertiary maternity units. Participants Two hundred and seventy-six babies born to 261 women expected to have a live birth before 32 0 weeks’ gestation. Interventions Deferred cord clamping (≥2?min) and immediate neonatal care with cord intact or immediate (≤20?s) clamping and immediate neonatal care after clamping. Main outcome measure Composite of death or adverse neurodevelopmental outcome at 2 years corrected age. Results Six babies born after 35 6 weeks were excluded. At 2 years corrected age, outcome data were not available for a further 52 children, leaving 218 for analysis (115 deferred clamping, 103 immediate clamping). Overall, 24/115 (21%) children allocated deferred clamping died or had an adverse neurodevelopmental outcome compared with 35/103 (34%) allocated immediate clamping; risk ratio (RR) 0.61 (95% CI 0.39 to 0.96); risk difference (RD) ?13% (95%?CI ?25% to ?1%). Multiple imputation for missing data gave an RR 0.69 (95% CI 0.44 to 1.09) and RD ?9% (95%?CI ?21% to 2%). Conclusions Deferred clamping and immediate neonatal care with cord intact may reduce the risk of death or adverse neurodevelopmental outcome at 2 years of age for children born very premature. Confirmation in larger studies is needed to determine the real benefits and harms. Trial registration number ISRCTN21456601 .