RT Journal Article
SR Electronic
T1 Future of clinical trials in the delivery room: time for pragmatism
JF Archives of Disease in Childhood - Fetal and Neonatal Edition
JO Arch Dis Child Fetal Neonatal Ed
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 102
OP 105
DO 10.1136/archdischild-2022-324387
VO 108
IS 2
A1 Colm Patrick Finbarr O'Donnell
A1 Janneke Dekker
A1 Mario Rüdiger
A1 Arjan B te Pas
YR 2023
UL http://fn.bmj.com/content/108/2/102.abstract
AB 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.Data sharing not applicable as no datasets generated and/or analysed for this study.