DOLFIN
Research type
Research Study
Full title
DOLFIN - Developmental Outcomes of Long Term Feed Supplementation in Neonates
IRAS ID
303421
Contact name
Morag Andrew
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN62323236
Duration of Study in the UK
5 years, 8 months, 31 days
Research summary
This study is designed to test whether adding a daily nutrient supplement (food substance) to the normal milk and weaning foods of babies born with Hypoxic Ischaemic Encephalopathy (where the brain did not receive enough oxygen around time of birth) or babies born premature (born less than 28 weeks of gestation) can help improve their neurological development in later childhood (such as how they think, play and interact with others). \n\nThe supplement contains substances that occur naturally in a healthy diet (and are often used as food supplements). Babies will be randomly allocated to receive supplement or a substance that looks the same (placebo).Supplement will be given twice a day mixed with a baby’s normal milk or weaning foods until the baby is one year of age. Parents will be supported by hospital staff. \n\nParents will also be asked to complete questionnaires at NNU discharge, 6, 12, 18, and 24 months about family circumstances, quality of life and their child’s neurological development. \n\nA small study has been carried out in the UK and the results were promising, but we need to find out more. We are aiming to include about 1,010 babies in order to be confident of finding out whether the supplement improves babies neurological development, or not. If the study tells us the supplement is effective, it might be given to babies as part of usual NHS care in the future. \n\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0009
Date of REC Opinion
14 Mar 2022
REC opinion
Further Information Favourable Opinion