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Arch Dis Child Fetal Neonatal Ed. 2019 Aug 1. pii: fetalneonatal-2019-316912. doi: 10.1136/archdischild-2019-316912. [Epub ahead of print]

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

Author information

1
Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
2
Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, Canada.
3
Department of Health Sciences, University of Leicester, Leicester, UK.

Abstract

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.

KEYWORDS:

neonatal care with cord intact; outcomes at 2 years corrected age

Conflict of interest statement

Competing interests: JD reports grants from NIHR during the conduct of the trial; LD reports memberships to CTUs funded by NIHR. All other authors have nothing to disclose.

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