At a glance
ClinicalIndex Comparison Record- ✓Born at or after 36 weeks gestation
- ✓Birth weight 1800g or more
- ✓Birth acidosis or requiring resuscitation at birth
- ✓Apgar score <6 at 10 minutes OR continued resuscitation at 10 minutes OR severe birth acidosis (pH ≤7.00 or Base deficit ≥16mmol/l)
- ✕Meet BAPM criteria for whole-body hypothermia
- ✕Less than two abnormalities on structured neurological examination (no encephalopathy)
- ✕Major congenital or chromosomal anomalies identified prior to randomisation
- ✕Birthweight <1800g
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy: A Multicentre Randomised Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Whole body hypothermia, Targeted normothermia, and 2 other interventions for Neonatal Encephalopathy and Newborn Asphyxia. Currently recruiting, targeting 426 participants across 39 sites in 2 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Whole-body hypothermia (33.5±0.5°C) initiated within 6 hours of birth and continued for 72 hours. The rectal temperature will be maintained at 33.5±0.5°C using a servo-controlled cooling machine.
The axillary temperature will be maintained at 37±0.5°C for the first 80 hours and any hyperthermia will be treated with a standardised protocol.
Neonatal intensive care monitoring and support including ventilatory and inotropic support as clinically indicated
The assessment will be carried out using the Bayley Scales of Infant and Toddler Development IV. In addition, all infants will have a detailed neurological examination, including Gross Motor Function Classification System (GMFCS) for cerebral palsy, vision, and hearing assessment. Babies who die or who cannot be assessed with the Bayley-IV due to severe disability will be allocated a Cognitive Scale Composite score one point below the basal test score. PARCA-R will be completed by the parents immediately.