Head or Heart Study - A dormant trial linkage feasibility study
Research type
Research Study
Full title
Methods of linking dormant trial data to determine the long-term effects of enriched nutrition in infancy.
IRAS ID
212148
Contact name
Ruth Gilbert
Contact email
Sponsor organisation
UCL Institute of Child Health
Clinicaltrials.gov Identifier
IG/00258, UCL IG number; Z6364106/2017/03/77, UCL Data Protection Registration
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
We aim to demonstrate the research potential of unconsented linkage between “dormant” (historical) trial data and administrative records for understanding long-term intervention effects; secondly, through doing this we aim to evaluate the long-term safety and effects of giving nutritional supplementation in infancy on cognitive development. A unique series of eleven infant feeding trials with over 4,000 participants recruited between 1982 and 2001 will constitute the cohort for this project.
The studies, which measured cognitive function at various points of follow up (e.g. IQ tests, Bayley Scales), struggled with low-response rates in later years, with retention as low as 12% by the age of 15 years. The effects of attrition severely limit the interpretability and validity of results, because participants who drop-out differ in unpredictable ways from participants who stay in the study. Consequently, using conventional follow-up methods, it remains unclear whether the expected cognitive benefits sustain into adolescence and adulthood.
Importantly, follow-up studies have also suggested that such interventions carry risks. For example, in preterm infants nutrient-enriched diets that promote early growth were found to be associated with worse plasma lipid profiles and higher blood pressure in adolescence. Only a long-term follow-up of trial participants can address the unexamined balance between cognitive benefits and suggested potential metabolic harms.
We aim to generate data of importance both to the public and the NHS. The findings on the effect of nutrition on educational outcomes will also be central for infant nutritional practices beyond the UK. The research could inform the ‘reactivation’ of a wealth of dormant trials in early childhood, particularly of interventions affecting growth and brain or lung development, where long-term follow up could reveal unexpected benefits or harms.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0556
Date of REC Opinion
22 Apr 2017
REC opinion
Favourable Opinion