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 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.