A randomized controlled trial of therapeutic hypothermia for neonatal hypoxic-ischemic encephalopathy

In this study, babiesadmitted to the NICU before 6 hours of life will be included according tospecified criteria including biochemical, physiological and clinical parameterssupporting a diagnosis of birth asphyxia. Infants will be randomized to standard care as per nursery protocol or standardcare plus 72 hours of hypothermia induced by a Phase-Changing Material (PCM)mattress. Infants will be assessed with cerebral MRI at 5 days ofage, a standardized neurological assessment (AmielTison) at 7 days of age,General Movements assessment (GMA) and computer-based infant movementassessment (CIMA) at 10-15 weeks and neurodevelopmental assessment at 24months. The persons performing and interpreting the outome(MRI, GMA/CIMA and neurodevelopmental outcome) will be blinded to the randomisation. Primary outcome will be MRI abnormalities at 5 days.Secondary outcomes will be neurological status at discharge, General Movementsassessment (GMA) at 10-15 weeks and neurodevelopmental disability at 24months.  We will also look at the role ofperinatal infection in brain injury by looking at placental evidence ofchorioamnionitis and serial serum IL 6 levels.