Hypothermia in Children After Trauma

The primary specific aim of this RCT is to determine the effect of induced moderate HYPO
(32-33 °C) after severe TBI in children on mortality at 3 months post injury. The primary
outcome measure will be the GOS; the primary time point for evaluation is 3 months. Further
secondary functional outcome measures will include the GOS - Extended Pediatrics (GOS - E
Peds), and Vineland Adaptive Behavior Scale (VABS) and will be assessed in conjunction with
the GOS at 6 and 12 months post injury.

The secondary hypotheses are based on the results and analysis of the Pilot Clinical Trial
(completed and recently published [Adelson et al. NEUROSURGERY. 56 (4): 740-754, 2005]).
These secondary hypotheses include that induced moderate hypothermia (HYPO) (32-33 °C) after
severe TBI in children and maintained for 48 h:

- will improve other outcome assessments including neurocognitive status on
performance-based neuropsychological testing across the domains of intellectual
development, learning and memory, language, motor and psychomotor skills, visuo-spatial
abilities, attention and executive function, and behavior at only 6 and 12 months after
injury;

- HYPO will improve long term outcome of all age ranges and across genders in infants,
young, preadolescent, and adolescent children; AND

- HYPO will lessen intracranial hypertension and lessen the intensity of therapy
necessary for control of ICP.

Based on these hypotheses, further secondary specific aims are proposed:

- Specific Aim 2: To determine the effect of early induced moderate HYPO (32-33°C) after
severe TBI in children on global function and neurocognitive outcomes in the areas of
intellectual ability/ development, memory and learning, and behavior at 6 and 12 months
post injury.

- Specific Aim 3: To determine the effect of early induced moderate HYPO after severe TBI
in children of different age ranges (< 6 y and 6- < 16 y) on mortality and 6 and 12
months functional and neurocognitive outcomes.

- Specific Aim 4: To determine the effect of early moderate HYPO after severe TBI in
children on reducing intracranial hypertension and maintaining adequate cerebral
perfusion pressure (CPP).