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

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 livebirth before 32+0 weeks gestation. Interventions: Deferred cord clamping (?2 minutes) and immediate neonatal care with cord intact, or immediate (?20 seconds) 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; relative risk (RR) 0.61 (95% confidence interval [CI] 0.39 to 0.96); risk difference (RD) -13% (95% CI -25% to -1%). Multiple imputation for missing data gave a 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