Hypothermia in Children After Trauma



Status:Archived
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:7/1/2011

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Pediatric Traumatic Brain Injury Consortium: Hypothermia


The primary hypothesis for this application for a multicenter phase III randomized clinical
trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic
brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3
months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).


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).


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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Brooklyn, New York 11203
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Charlotte, North Carolina 28207
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Miami, Florida 33136
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New Hyde Park, New York 11040
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445 E 69th St
New York, New York 10021
(212) 746-1067
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
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200 1st St SW
Rochester, Minnesota 55905
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Seattle, Washington 98195
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