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Cooling in Mild Encephalopathy
Sponsor: Imperial College London
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.
Official title: Whole-body Hypothermia Versus Normothermia in Mild Neonatal Encephalopathy: A Multicentre Randomised Controlled Trial
Key Details
Gender
All
Age Range
1 Hour - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
426
Start Date
2024-03-15
Completion Date
2030-01-01
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Whole body hypothermia
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.
Targeted normothermia
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.
Supportive neonatal intensive care
Neonatal intensive care monitoring and support including ventilatory and inotropic support as clinically indicated
Follow up assessment at 2 years of age
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.
Locations (39)
Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Italy
William Harvey Hospital
Ashford, United Kingdom
St Peters Hosptial
Ashford, United Kingdom
Birmingham Heartlands
Birmingham, United Kingdom
Royal Bolton Hosptial
Bolton, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
St Michael's Hospital
Bristol, United Kingdom
Southmead Hosptial
Bristol, United Kingdom
Rosie Maternity Hosptial, Addenbrookes
Cambridge, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Darent Valley Hospital
Dartford, United Kingdom
Simpson Centre for Reproductive Health NHS Lothian
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Princess Royal Hospital
Haywards Heath, United Kingdom
Leeds centre for Newborn Care (Leeds General Infirmary)
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Liverpool Women's Hospital
Liverpool, United Kingdom
Homerton University Hospital
London, United Kingdom
Imperial College Healthcare NHS FT
London, United Kingdom
Newham General Hosptial
London, United Kingdom
Northwick Park Hospital
London, United Kingdom
Queen's Hospital, Barking
London, United Kingdom
Royal London Hospital
London, United Kingdom
St Thomas Hospital
London, United Kingdom
Whipps Cross Hospital
London, United Kingdom
Luton and Dunstable Hospital
Luton, United Kingdom
St Mary's Hospital
Manchester, United Kingdom
Wythenshawe Hosptial
Manchester, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Queens Medical Centre Nottingham
Nottingham, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Derriford Hosptial
Plymouth, United Kingdom
Turnbridge Wells Hospital
Royal Tunbridge Wells, United Kingdom
University Hospital of Wales
Wales, United Kingdom
Whiston Hospital
Whiston, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
Worthing Hospital
Worthing, United Kingdom