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

Armstrong-Buisseret, Lindsay; Powers, Katie; Dorling, Jon; Bradshaw, Lucy; Johnson, Samantha; Mitchell, Eleanor; Duley, Lelia

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 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.

Citation

Armstrong-Buisseret, L., Powers, K., Dorling, J., Bradshaw, L., Johnson, S., Mitchell, E., & Duley, L. (2020). Randomised trial of cord clamping at very preterm birth: outcomes at 2 years. Archives of Disease in Childhood. Fetal and Neonatal Edition, 105(3), 292-298. https://doi.org/10.1136/archdischild-2019-316912

• Journal Article Type: Article
• Acceptance Date: Jul 17, 2019
• Online Publication Date: Aug 1, 2019
• Publication Date: 2020-05
• Deposit Date: Jul 29, 2019
• Publicly Available Date: Aug 2, 2019
• Journal: Archives of Disease in Childhood - Fetal and Neonatal Edition
• Electronic ISSN: 1468-2052
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 105
• Issue: 3
• Pages: 292-298
• DOI: https://doi.org/10.1136/archdischild-2019-316912
• Keywords: Neonatal care with cord intact; Outcomes at 2 years corrected age.
• Public URL: https://nottingham-repository.worktribe.com/output/2351514
• Publisher URL: https://fn.bmj.com/content/early/2019/08/01/archdischild-2019-316912