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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.
- neonatal care with cord intact
- outcomes at 2 years corrected age
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Footnotes
Contributors The trial was conceived by LD and Gill Gyte. The protocol, trial procedures and strategies for recruitment and consent were developed in consultation with a broad range of stakeholders including parent representatives, clinicians, researchers, National Institute for Health Research (NIHR) preterm birth programme grant steering group, independent Trial Steering Committee, Data Monitoring Committee and the Nottingham Clinical Trials Unit. The paper was drafted by LA-B with input and comments from other authors. All authors have read and agreed the final paper.
Funding This trial is independent research funded by the NIHR under its Programme Grants for Applied Research funding scheme (RPPG0609-10107).
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The funder had no role in study design, conduct, analysis or reporting.
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.
Ethics approval Nottingham REC 2 (NRES reference 12/EM/0283).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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