HIE-Connect
Research type
Research Study
Full title
Brain Functional Connectivity and Network Organisation in Children with Hypoxic Ischaemic Encephalopathy Who Underwent Therapeutic Hypothermia: Characteristics and Associations with Outcomes
IRAS ID
336927
Contact name
Ela Chakkarapani
Contact email
Duration of Study in the UK
4 years, 7 months, 1 days
Research summary
Hypoxic-ischaemic encephalopathy (HIE) is a condition resulting from the lack of oxygen around birth, characterised by brain damage in the newborn period and high risk of disabilities. Currently, therapeutic hypothermia or cooling therapy is the standard treatment for moderate or severe HIE, in high-income settings, aiming to improve survival and neurodevelopmental outcomes. Despite improved outcomes after cooling therapy, infants with HIE still face cognitive difficulties at school age (10%–40%).
We would like to better understand how the functioning of the brain develops in the first year of life after receiving cooling therapy for HIE compared with children who did not have HIE. We will also aim to understand how the early development of the functioning of the brain is related to later intellectual development and factors around the birth or newborn period. The information we gather from this study will help us to improve the outcome of children who have had HIE.
Brain development will be assessed using electroencephalography (EEG), which measures the electrical signals in the brain using sensors placed on the scalp and functional near-infrared spectroscopy (fNIRS), which uses light to measure changes in blood flow in the brain. Both methods are safe and painless. EEG and fNIRS will be conducted at two time points when the infants are three and six months old. At the three-month visit, we will also video record the infant's movement and 10 infants chosen sequentially will undergo brain MRI scan. An optional visit will happen at nine months of age.
We aim to enrol up to 45 infants who were cooled for HIE and up to 45 healthy infants. Infants cooled for HIE will be identified from up to seven NHS hospitals/trusts. All study visits will take place at Cardiff University Campus.
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0130
Date of REC Opinion
22 May 2024
REC opinion
Further Information Favourable Opinion