RT Journal Article
SR Electronic
T1 Implementing two-stage consent pathway in neonatal trials
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 79
OP 82
DO 10.1136/archdischild-2021-322960
VO 108
IS 1
A1 Eleanor Mitchell
A1 Sam J Oddie
A1 Jon Dorling
A1 Chris Gale
A1 Mark John Johnson
A1 William McGuire
A1 Shalini Ojha
YR 2023
UL http://fn.bmj.com/content/108/1/79.abstract
AB Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.Data sharing not applicable as no datasets generated and/or analysed for this study.