Cognition and Development in Infants and Children with Liver Disease
Research type
Research Study
Full title
A Longitudinal Investigation of Cognition, Development and Brain Development in Infants and Children with Chronic Liver Disease.
IRAS ID
258414
Contact name
Grainnne McAlonan
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
3 years, 10 months, 12 days
Research summary
Hepatic encephalopathy (HE) is a serious complication of chronic liver disease (CLD) caused by accumulation of toxic substances in the bloodstream that are normally removed by the liver. It manifests as a wide spectrum of neurological and psychiatric abnormalities, ranging from subclinical alterations to coma. It is associated with poorer quality of life, impaired daily functioning and reduced survival, and does not necessarily normalise post-liver transplantation in those with established HE.
Covert HE (CHE), a milder form of HE is difficult to identify in routine clinical practice, as patients tend to be apparently asymptomatic with no particular findings on routine physical examination/investigations. It can be detected by neuropsychological assessment and neurophysiological testing in adults but has not been comprehensively studied in children, and has never been studied in infants.
The project will use cognitive tasks, behavioural observations, parental interviews and questionnaires to assess brain function in infants and pre-school children with primary biliary atresia. Repeated measures of cognitive tasks/behavioural observations will allow development over time to be measured. Liver function and inflammatory blood markers will be measured contemporaneously.
We will be able to reference our findings to data acquired in the same way with infants, from existing cohorts of infants within the research team's ‘Eurosibs’ multisite studies, across 10 sites in 7 European countries.
Our aim is to also use non-invasive brain magnetic resonance imaging (MRI) together with behavioural measures and symptom ratings to map early brain development in infants with liver disease. In this way we hope to discover biomarkers indicating an increased risk of developmental difficulty in this population.
The protocols used in this study are based on those previously approved for fetal, neonatal and infant MRI.
REC name
London - South East Research Ethics Committee
REC reference
20/LO/0307
Date of REC Opinion
24 Mar 2020
REC opinion
Unfavourable Opinion