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Design: Randomised controlled trial (RCT).
Allocation: Concealed web based algorithm to stratified by study site and age.
Blinding: Treating doctors not masked—investigators assessing outcome were masked.
Setting: Multinational, multicentre paediatric intensive care unit—75% patients from three paediatric intensive care units (Davis, California; Dallas, Texas; Pittsburgh, Pennsylvania) in USA.
Patients: Age 0–17 years non-penetrating brain injury; Glasgow coma scale (GCS) score 3–8 (motor score <6), available for randomisation within 6 h of injury. Excluded if any of: normal CT head, Glasgow coma scale score 3, unreactive pupils, hypotension, uncorrectable coagulopathy, hypoxia, multiple trauma, suspected pregnancy.
Intervention: Thirty-nine patients were randomised to hypothermia (T32–33°C) for 48 h followed by slow rewarming and 38 patients were randomised to …