|Trial name or title||Pediatric traumatic brain injury consortium: hypothermia.|
|Methods||Treatment, Randomized, Single Blind (outcome assessor), single group assignment, efficacy study.|
|Participants||TBI patients under 16 years of age, with a GCS </= 8.|
|Interventions||Patients in the treatment arm will be cooled to 32-33C for 48 hours and then slowly rewarmed.|
To determine the effect of induced moderate hypothermia (32-33C) after severe TBI in children on mortality.
To determine the effect of hypothermia after severe TBI in children on global function and neurocognitive outcomes in the areas of intellectual ability/development, memory and learning, and behaviour.
To determine the effect of hypothermia after severe TBI in children of different age ranges (<6y and 6 to <16y) on mortality and 6- and 12-month functional and neurocognitive outcomes.
To determine the effect of hypothermia after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure (CPP).
|Starting date||November 2007|
|Contact information||David Adelson +1(412)692-6347 firstname.lastname@example.org|
Danielle Brown +1(412)692-8794 email@example.com
|Notes||Phase III Clinical Trial.|
The sites participating in this trial are: Duke University, Durham, North Carolina; Johns Hopkins University, Baltimore, Maryland; Schneider Children’s Hospital, New Hyde Park, New York; Penn State University College of Medicine, Hershey, Pennsylvania; University of California, Davis, Sacramento, California; Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; University of Miami, Coral Gables, Florida; University of North Carolina, Chapel Hill, North Carolina; University of Pittsburgh, Pittsburgh, Pennsylvania; University of Tennessee, Memphis, Tennessee; University of Texas Southwestern, Dallas, Texas; University of Washington, Seattle, Washington.