Implementing two-stage consent pathway in neonatal trials

Eleanor Mitchell, Sam J Oddie, Jon Dorling, Chris Gale, Mark John Johnson, William McGuire, Shalini Ojha

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)79-82
JournalArchives of disease in childhood-Fetal and neonatal edition
Issue number1
Early online date23 Dec 2021
Publication statusPublished - 15 Dec 2022

Bibliographical note

© Author(s) (or their employer(s)) 2021

Cite this