Infant MRI following HIE: Pilot Study
Research type
Research Study
Full title
Infant CoolMRI Pilot Study: Investigation of brain structure and function in infants who have received therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy.
IRAS ID
313618
Contact name
Ela Chakkarapani
Contact email
Sponsor organisation
Research and Enterprise, University of Bristol
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Newborn babies who suffer from brain damage due to lack of oxygen around birth (hypoxic-ischaemic encephalopathy) receive three days of cooling therapy and intensive care, commenced within 6 hours of age, to reduce long-term disabilities and death. Whilst outcomes improve with the use of cooling therapy, survivors still have an increased risk of neurodevelopmental disability, as well as intellectual disabilities at school-age.
We aim to investigate brain development from birth until 9 months of age in infants treated with cooling therapy and compare this to healthy infants to determine any underlying impairments to brain structure and function assessed using brain MRI scan and electroencephalogram (EEG). MRI scans, EEG, brain blood flow and visual tracking will be assessed at 4 time points up to 9 months old. In this pilot study we will assess up to 5 infants who were cooled for hypoxic-ischaemic encephalopathy and 5 healthy infants. Healthy infants will not have any neurological problems at birth and will be recruited from Bristol, Cwmbran and Cardiff. The purpose of this pilot study is to assess the feasibility of recruiting and acquiring data, refine the MRI sequences for obtaining good quality images, and identify barriers and facilitators for undertaking a larger study with this protocol.
The initial brain MRI scan will be obtained at the hospital where the infants undergo cooling therapy or the hospital of birth including the University Hospital Bristol and Weston Foundation NHS Trust (St Michael’s neonatal intensive care unit), North Bristol NHS Trust (Southmead neonatal intensive care unit), Grange Hospital and Cardiff and Vale University Health Board. Subsequent assessments will occur at The Cardiff University Brain Research Imaging Centre (CUBRIC), and Tower Building, Cardiff.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0135
Date of REC Opinion
19 Jul 2023
REC opinion
Further Information Favourable Opinion