Parental experiences and views of neonatal trials (PARENT)v1
Research type
Research Study
Full title
Parental experiences and views of neonatal trials (PARENT)
IRAS ID
162139
Contact name
Nicholas D Embleton
Contact email
Sponsor organisation
Newcastle Hospitals NHS FOundation Trust
Clinicaltrials.gov Identifier
NIHR HTA funding for SIFT, NCT01727609; MREC number for SIFT trial, 13/EM/0030; Sponsor R&D number for SIFT, 6523; Sponsor R&D number for ELFIN, 6602
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Clinical trials in the perinatal period present specific issues for parents and staff. Parents may be approached at a stage when their infant is receiving care on a neonatal unit, where the infant may be sick or there are concerns about longer term survival. All of these factors are likely to impact on recruitment. Newborn infants are a vulnerable group because they are unable to consent for themselves. Deciding when it is appropriate to approach parents requires a high level of experience and understanding. Many parents appear happy to consider being involved in multiple studies but this area has not been subject to detailed qualitative study in the context of multiple RCTs. The aim of this study (PARENT) is to explore the perceptions and experiences of parents of infants’ who were asked to take part in more than one study. There are two large trials currently taking place in neonatal units: SIFT (Speed of Increasing milk Feeds Trials www.npeu.ox.ac.uk/sift) and ELFIN (Enteral Lactoferrin in Neonates www.npeu.ox.ac.uk/elfin). We will use the SIFT and ELFIN studies and approach parents to take part in this additional PARENT study so we can explore the experiences and perceptions of parents whose infants were approached to join more than one research study.
REC name
HSC REC A
REC reference
15/NI/0021
Date of REC Opinion
20 Feb 2015
REC opinion
Further Information Favourable Opinion