Cooling in Mild Encephalopathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-6
SponsorImperial College London
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
Infants who meet the BAPM criteria for whole-body hypothermia
Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.
Infants with major congenital or chromosomal anomalies identified prior to randomisation.
Infants with birthweight <1800g.
Trial design
Treatments tested in this trial
- Whole body hypothermia
- Targeted normothermia
- Supportive neonatal intensive care
- Follow up assessment at 2 years of age
Treatment groups
426 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov