426
Participants
Start Date
March 15, 2024
Primary Completion Date
January 1, 2030
Study Completion Date
January 1, 2030
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.
RECRUITING
"Neonatal Unit, Università degli Studi della Campania Luigi Vanvitelli", Naples
RECRUITING
Medway Maritime Hospital, Gillingham
RECRUITING
Liverpool Women's Hospital, Liverpool
RECRUITING
Homerton University Hospital, London
RECRUITING
Imperial College Healthcare NHS FT, London
RECRUITING
William Harvey Hospital, Ashford
RECRUITING
Royal Sussex County Hospital, Brighton
RECRUITING
St Michael's Hospital, Bristol
RECRUITING
Darent Valley Hospital, Dartford
RECRUITING
Princess Royal Hospital, Haywards Heath
NOT_YET_RECRUITING
John Radcliffe Hospital, Oxford
RECRUITING
Derriford Hosptial, Plymouth
RECRUITING
Turnbridge Wells Hospital, Royal Tunbridge Wells
NOT_YET_RECRUITING
Southampton General Hospital, Southampton
RECRUITING
Worthing Hospital, Worthing
Imperial College London
OTHER