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Deferred consent for the enrolment of neonates in delivery room studies: strengthening the approach
  1. Maria C den Boer1,2,
  2. Mirjam Houtlosser2,
  3. Elizabeth E Foglia3,
  4. Peter G Davis4,
  5. Anton H van Kaam5,
  6. Camille O F Kamlin6,
  7. Georg M Schmölzer7,
  8. Martine C de Vries2,8,
  9. Arjan B te Pas1
  1. 1 Neonatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2 Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, The Netherlands
  3. 3 Division of Neonatology, Department of Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
  4. 4 Newborn Research, Royal Women’s Hospital, Melbourne, Victoria, Australia
  5. 5 Neonatology, Emma Children’s Hospital AMC, Amsterdam, The Netherlands
  6. 6 Division of Newborn Services, Royal Women’s Hospital, Melbourne, Victoria, Australia
  7. 7 Neonatology, Royal Alexandra Hospital, Edmonton, Alberta, Canada
  8. 8 Pediatrics, Leiden University Medical Center, Leiden, The Netherlands
  1. Correspondence to Maria C den Boer, Neonatology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands; m.c.den_boer{at}lumc.nl

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Introduction

The transition from fetal to newborn life involves major cardiopulmonary changes. Most neonates adapt to these changes without assistance, but approximately 10% of neonates require support and less than 1% require cardiac resuscitation.1–3 Improving the provision of care to neonates during transition can save lives and reduce morbidities, but can be arduous.4 Evidence regarding the best care for neonates requiring interventions in the delivery room (DR) is often lacking or of poor quality.5 There is a lack of uniformity in DR management, indicated by the existence of differing local, national and international resuscitation guidelines. Improving the evidence base for DR interventions is recommended, as this improves uniformity, thus safety and efficacy of DR interventions, and thereby neonatal outcomes.1 6 7 However, conducting research in the DR can be ethically challenging.

Conducting clinical research requires informed consent from participants or their proxies. This implies that parents need to consent to their child’s participation before the start of study procedures. Hence, parents need to consent for DR studies before the birth of their child. We will refer to this traditional approach as prospective consent. Obtaining ethically appropriate prospective consent from parents, faced with an imminent premature birth or their newborn needing emergency resuscitation, is complicated for various reasons. First, emotional and physical distress of the parents complicates the consent process,8–11 and approaching parents in such a stressful situation is burdensome.12 Second, many of these infants never become eligible for specific DR studies, reflecting an unnecessary burden on both parents and investigators.13 Above all, time to approach parents for prospective consent is often lacking in situations of imminent premature birth or emergency resuscitation. Neonates requiring resuscitation in these situations are therefore often excluded from DR studies, and these infants may be at the highest risk of a …

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