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Future of clinical trials in the delivery room: time for pragmatism
  1. Colm Patrick Finbarr O'Donnell1,2,
  2. Janneke Dekker3,
  3. Mario Rüdiger4,5,
  4. Arjan B te Pas6
  1. 1 Neonatal Unit, National Maternity Hospital, Dublin, Ireland
  2. 2 School of Medicine, University College Dublin School of Medicine, Dublin, Ireland
  3. 3 Pediatrics, Division of Neonatology, Leiden University Medical Center, Leiden, The Netherlands
  4. 4 Department for Neonatology and Paediatric Intensive Care Medicine; Medizinische Fakultät, Technische Universitat Dresden, Dresden, Germany
  5. 5 Saxony Centre for Feto-Neonatal Health, Medizinische Fakultät, Technische Universitat Dresden, Dresden, Germany
  6. 6 Neonatology, Leiden University Medical Center, Leiden, The Netherlands
  1. Correspondence to Professor Colm Patrick Finbarr O'Donnell, Neonatal Unit, National Maternity Hospital, Dublin, Ireland; codonnell{at}nmh.ie

Abstract

Despite increased amounts of research, most of the evidence that supports treatment of newborns in the delivery room is rated ‘low’ rather than ‘high’ quality. This assessment stems largely from a lack of evidence from clinical trials. When trials have been performed, the evidence has often been downgraded due to enrolment of small or poorly representative samples, and for lack of blinding of caregivers and outcome assessors. Delivery room trials present particular challenges when obtaining consent, enrolling participants, taking measures to limit bias and identifying appropriate outcome measures. We hope our suggestions as to how future delivery room trials could be more pragmatic will inform the design of large studies that are necessary to allow clinical practice to evolve.

  • Neonatology
  • Resuscitation

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

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Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

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  • Contributors CPFO'D and ABtP conceived the manuscript. CPFO'D wrote the first draft, while JD, MR and ABtP revised it critically for important intellectual content. All authors approve of the final version to be published.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Commissioned; externally peer reviewed.