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Sponsors and Collaborators: |
University of Pittsburgh National Institute of Neurological Disorders and Stroke (NINDS) |
Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00222742 |
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 TBI in children and maintained for 48 h will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).
Condition | Intervention | Phase |
Traumatic Brain Injury |
Procedure: induced moderate hypothermia |
Phase III |
MedlinePlus related topics: | Head and Brain Injuries Hypothermia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study |
Official Title: | Pediatric Traumatic Brain Injury Consortium: Hypothermia |
Estimated Enrollment: | 340 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Induced hypothermia
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Procedure: induced moderate hypothermia
Subjects assigned to the treatment arm will be cooled to 32-33C for 48 hours and then slowly rewarmed.
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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: 1) 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; 2) HYPO will improve long term outcome of all age ranges and across genders in infants, young, preadolescent, and adolescent children; and 3) 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:
Ages Eligible for Study: | up to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: P. David Adelson, MD | 412-692-6347 | david.adelson@chp.edu |
Contact: S. Danielle Brown, RN, MS | 412-692-8794 | brownds2@upmc.edu |
United States, California | |||||
University of California, Davis Medical Center | Not yet recruiting | ||||
Sacramento, California, United States, 95817 | |||||
Principal Investigator: Kiarash Shahlaie, MD, PhD | |||||
United States, Florida | |||||
University of Miami | Recruiting | ||||
Miami, Florida, United States, 33136 | |||||
Principal Investigator: John Ragheb, MD | |||||
United States, Maryland | |||||
Johns Hopkins University | Not yet recruiting | ||||
Baltimore, Maryland, United States, 21287 | |||||
Principal Investigator: George Jallo, MD | |||||
United States, New York | |||||
Schneider Children's Hospital | Recruiting | ||||
New Hyde Park, New York, United States, 11040 | |||||
Principal Investigator: Stephen Schneider, MD | |||||
United States, North Carolina | |||||
University of North Carolina | Not yet recruiting | ||||
Chapel Hill, North Carolina, United States, 25799 | |||||
Principal Investigator: Stephen Leinenweber, MD | |||||
Duke University | Recruiting | ||||
Durham, North Carolina, United States, 27710 | |||||
Contact: Gerald Grant, MD 919-684-5013 gerald.grant@duke.edu | |||||
Principal Investigator: Gerald Grant, MD | |||||
Sub-Investigator: Mary Hartman, MD | |||||
United States, Ohio | |||||
Cincinnati Children's Hospital Medical Center | Recruiting | ||||
Cincinnati, Ohio, United States, 47229-3039 | |||||
Contact: Karin Bierbrauer, MD 513-636-4726 karin.bierbrauer@cchmc.org | |||||
Principal Investigator: Karin Bierbrauer, MD | |||||
United States, Pennsylvania | |||||
University of Pittsburgh/Children's Hospital of Pittsburgh | Recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15213 | |||||
Contact: Michael J Bell, MD 412-692-5164 bellmj4@upmc.edu | |||||
Principal Investigator: Michael Bell, MD | |||||
Penn State Hershey Medical Center | Recruiting | ||||
Hershey, Pennsylvania, United States, 17033 | |||||
Contact: Neal J Thomas, MD, M.Sc. 717-531-5337 nthomas@psu.edu | |||||
Principal Investigator: Neal Thomas, MD | |||||
United States, Tennessee | |||||
University of Tennessee | Not yet recruiting | ||||
Memphis, Tennessee, United States, 38163 | |||||
Contact: Shelley D Timmons, MD, PhD 901-448-6375 stimmons@utmem.edu | |||||
Principal Investigator: Shelley D Timmons, MD, PhD | |||||
United States, Texas | |||||
University of Texas, Southwestern | Recruiting | ||||
Dallas, Texas, United States, 75235 | |||||
Principal Investigator: Pam Okada, MD | |||||
Sub-Investigator: Marita Thompson, MD | |||||
Sub-Investigator: Steven Kernie, MD | |||||
United States, Washington | |||||
University of Washington | Not yet recruiting | ||||
Seattle, Washington, United States, 98104 | |||||
Principal Investigator: Randall Chesnut, MD | |||||
Sub-Investigator: Monica Vavilala, MD |
University of Pittsburgh |
National Institute of Neurological Disorders and Stroke (NINDS) |
Principal Investigator: | P. David Adelson, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( P. David Adelson, MD ) |
Study ID Numbers: | 1R01-NS052478-01, 1R01NS052478-01 |
First Received: | September 16, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00222742 |
Health Authority: | United States: Institutional Review Board |
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