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Randomised trial of cord clamping and initial stabilisation at very preterm birth
  1. Lelia Duley1,
  2. Jon Dorling2,
  3. Angela Pushpa-Rajah3,
  4. Sam J Oddie4,
  5. Charles William Yoxall5,
  6. Bernard Schoonakker6,
  7. Lucy Bradshaw1,
  8. Eleanor J Mitchell1,
  9. Joe Anthony Fawke7
  10. on behalf of the Cord Pilot Trial Collaborative Group
    1. 1 Nottingham Clinical Trials Unit, Queen’s Medical Centre, University of Nottingham, Nottingham, UK
    2. 2 Early Life Research Group, Queen’s Medical Centre, University of Nottingham, Nottingham, UK
    3. 3 Department of Dermatology, Guy’s Hospital, London, UK
    4. 4 Centre for Reviews and Dissemination, Hull York Medical School, University of York, Heslington, York, UK
    5. 5 Neonatal Unit, Liverpool Women’s Hospital, Liverpool, UK
    6. 6 Neonatal Intensive Care Unit, City Hospital, Nottingham, UK
    7. 7 Neonatal Unit, Leicester Royal Infirmary, Leicester, UK
    1. Correspondence to Professor Lelia Duley, Nottingham Clinical Trials Unit, Queen’s Medical Centre, University of Nottingham, Nottingham NG7 2UH, UK; lelia.Duley{at}nottingham.ac.uk

    Abstract

    Objectives For very preterm births, to compare alternative policies for umbilical cord clamping and immediate neonatal care.

    Design Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes.

    Setting Eight UK tertiary maternity units.

    Participants 261 women expected to have a live birth before 32 weeks, and their 276 babies.

    Interventions Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping.

    Main outcome measures Intraventricular haemorrhage (IVH), death before discharge.

    Results 132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35+6 weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) −5.9% (95% CI −12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 47 of 132 (36%), respectively; RD −3.5% (−14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers.

    Conclusions This is promising evidence that clamping after at least 2 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.

    Trial registration ISRCTN 21456601.

    • preterm birth
    • randomised trial
    • cord clamping
    • neonatal care with umbilical cord intact
    • intraventricular haemorrhage

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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    Footnotes

    • Contributors The study was conceived by LD and GG. The protocol, trial procedures and strategies for recruitment and consent were developed in consultation with a board range of stakeholders including parent representatives, clinicians, researchers, the NIHR programme grant steering group and the Nottingham Clinical Trials Unit. The paper was drafted by LD, with comments from other authors. All authors have read and agreed the final paper.

    • Funding This trial is independent research funded by the National Institute for HealthResearch (NIHR) under its Programme Grants for Applied Research funding scheme (RPPG-0609-10107). The views expressed are those of the authors and not necessarily thoseof the NHS, the NIHR or the Department of Health. The funder had no role in study design,conduct, analysis or reporting.

    • Competing interests All authors declare no support from any organisation for the submitted work other than the NIHR programme grant; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; the grant funded research included development of a neonatal resuscitation trolley now marketed as ‘LifeStart’ and purchased by two sites for use in this trial, several authors were involved in development of the trolley but have no further relationship with the manufacturer; no other relationships or activities that could appear to have influenced the submitted work.

    • Patient consent Obtained.

    • Ethics approval Nottingham REC 2 (NRES reference 12/EM/0283).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Patient level data and the dataset presented here are available from the corresponding author. Participant consent for data sharing was not obtained but the presented data are anonymised and risk of identification is low.

    • Collaborators Cord Pilot Trial Collaborative Group: Nottingham Clinical Trials Unit: Lelia Duley (chief investigator). Lindsay Armstrong-Buisseret (trial manager from November 2015). Brian Barnes (data coordinator). Lucy Bradshaw (statistician). Natalie Hutchings (trial administrator). Eleanor Mitchell (senior trial manager). Angela Pushpa-Rajah (trial manager May 2013-July 2015). Keith Whittaker (database programmer). Trial Management group: Lucy Bradshaw, Jon Dorling, Lelia Duley, Eleanor Mitchell, Angela Pushpa-Rajah (chair). Trial Steering Committee: Lucy Bradshaw (statistician), Kate Branchett, Mike Clarke (chair), Richard Cooke, Jon Dorling (neonatologist), Lelia Duley (chief investigator), Liz Goddard, Sara Kenyon, Angela Pushpa-Rajah (trial manager), Philip Steer. Data Monitoring Committee: Douglas Altman (chair), Declan Devane, Andrew Shennan, Ben Stenson. Patient and public involvement: Jane Abbott (Bliss, the special care baby unit charity) (until June 2014), Zoe Chivers (Bliss), Gill Gyte (NCT, National Childbirth Trust). Cranial ultrasound adjudication: Lindsay Armstrong-Buisseret, Lucy Bradshaw, Robert Dineen, Jon Dorling, Lelia Duley, Eleanor Mitchell. Clinical advisors: David Field, Jim Thornton, William Tarnow-Mordi. Writing committee: Lucy Bradshaw, Rob Dineen, Jon Dorling, Lelia Duley (chair) and Eleanor Mitchell. Collaborators by site (total number of women recruited). Aberdeen Maternity Hospital (13): Medhat Ezzat, Nikolaus Kau, Vijender Kistareddy, Annie Robertson: Bradford Royal Infirmary (43): Amal Mighell, Sam Oddie, Kelly Young City Hospital (39): Dushyant Batra, Bernard Schoonakker, Carys Smith, Kumar Swamy Homerton University Hospital (18): Narendra Aladangady, Amit Kandhari, Elaine van der. Pool: Leicester Royal Infirmary (39): Ros Astles, Joe Fawke, Marie Hubbard, Penny McParland Liverpool Women’s Hospital (69): Margaret Thomas, Andrew Weeks, Charles William Yoxall New Cross Hospital (14): Kate Cheshire, David Churchill, Tilly Pilley, Melanie Sutcliffe Queen’s Medical Centre (26): George Bugg, Jon Dorling, Yvonne Hooton, Gill Kirkwood.

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