Dolphin Pre-school Study v1
Research type
Research Study
Full title
Neurodevelopmental outcomes of pre-school children with risk factors for neurodisability, following neurotrophic supplementation in infancy
IRAS ID
139143
Contact name
Peter B Sullivan
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust Research & Development Department
Research summary
Do pre-school children with risk factors for neurodisability who received dietary neurotrophic supplementation in infancy have better cognitive outcomes than children who received placebo?
This is a follow-up study of a group of children who took part in two Randomised Control Trials (RCTs). The RCTs investigate whether dietary supplementation with nutrients essential to healthy brain growth and repair (neurotrophic factors – Docosahexaenoic acid, choline and uridine-5-monophosphate) administered in the first two years of life improves neurodevelopmental outcomes in infants at risk of neurodisability. The RCTs runs until January 2015.
Difficulties with thinking, attention and learning (cognition) are common in children born very pre-term and in infants who have a brain injury around the time of birth. Cognitive difficulties can impact on learning, social participation and social relationships. Cognitive difficulties may become more obvious as children approach school age when they are expected to complete more challenging tasks and when it is possible to test a wider range of cognitive skills than in infancy.
Participants in this study will be the 80 children from the RCTs who received dietary supplementation. The cognitive skills of each child will be assessed once between the ages of 3-5 years, using a range of standardised cognitive assessments and new standardised assessments designed to identify early attention difficulties. The performance of children who received the neurotrophic supplement will be compared to that of children who received the placebo to identify any differences in cognitive ability between the two groups. The study will run over 2 years, starting in January 2014. There are few interventions aimed at improving the cognitive outcome of children with risk factors for neurodisability. If successful, this simple intervention could improve the cognitive skills of large numbers of children, with potentially important consequences for education, employment, participation and social relationships.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
14/LO/0101
Date of REC Opinion
4 Feb 2014
REC opinion
Favourable Opinion