Cooling in Mild Encephalopathy

The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS. The main questions it aims to answer are: 1. Does whole-body cooling (33.5±0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37±0.5°C)? 2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds? Participants will have the following interventions: * Randomisation into one of the following groups * Whole body hypothermia group * Targeted normothermia group * Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age. Researchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.

NCT Number	NCT05889507
Lead Sponsor	Imperial College London
Conditions	Neonatal Encephalopathy, Newborn Asphyxia
Enrollment	426 participants
Start Date	2024-03-15
Primary Completion	2030-01-01 (estimated)
Study Completion	2030-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-06