COMET - Cooling in Mild Encephalopathy trial

One in every 1,000 babies born in the UK experiences mild encephalopathy. These babies are often irritable at birth and may have difficulty with breathing and feeding, but they typically recover within a few days with supportive care. However, recent data suggests that many of these babies may have lower cognitive abilities at age 2, and about 5% may develop severe disability. By school age, nearly 38% require special educational support, which places a significant burden on families. The BAPM recommends that cooling therapy for mild HIE be urgently tested in clinical trials.

The COMET trial aims to evaluate the safety, efficacy, and cost-effectiveness of cooling therapy for babies with mild encephalopathy. The trial will recruit 426 term babies diagnosed with mild HIE from several NHS hospitals, following a detailed neurological examination and aEEG assessment. Babies will be randomly assigned to receive either cooling therapy (for 3 days) or usual care (normothermia) within 6 hours of birth, after informed parental consent. Randomisation will occur at the hospital of birth.

Eligible hospitals must have a servo-controlled cooling device and an aEEG machine. If a baby is born at a non-cooling centre, they will be transferred to a hospital with cooling facilities. All babies will undergo an MRI scan before discharge. The primary outcome will be Bayley IV cognitive scores at age 2, and consent will also be sought for follow-up at school age

Funding: National Institute of Health and Care Research, Health Technology Assessment
Sponsor: Imperial College London

ClinicalTrials.gov Identifier: NCT05889507

Key Documents for the Trial:

• COMET Trial Protocol v4.0
• Parent Information Sheet (PIS) for Main Trial
• PIS for Video Recording of Neurological Assessment
• Informed Consent Form (ICF) for Main Trial
• ICF for Video Recording of Neurological Assessment
• Transport Consent Form: Transfer to Cooling Centre
• Telephone consent form
• Expanded Modified Sarnat staging - SOP (pdf)

 Key reference videos of the Trial:

• Parent information explanatory video
• Expanded Modified Sarnat Stage video explanation.

Comet pilot trial published in Jama

COMET trial pilot randomised controlled trial results published in JAMA Network Open 2024