Hypothermia in Children After Trauma
- Conditions
- Traumatic Brain Injury
- Interventions
- Procedure: induced moderate hypothermia
- Registration Number
- NCT00222742
- Lead Sponsor
- Phoenix Children's Hospital
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 90
- Patients with a GCS </= 8
- Glasgow Motor Score < 6
- Closed head injury
- Age 0 < 18 y
Exclusion Criteria
- Unavailable to initiate cooling within 6 hours of injury
- Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function
- Normal initial CT scan (No blood, fracture, swelling, and/or shift)
- Penetrating brain injury
- No known mechanism of injury
- Unknown time of injury
- Uncorrectable coagulopathy (PT/PTT > 16/40 sec, INR > 1.7)
- Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min)
- Documented Hypoxic episode (O2 saturation < 94% for > 30 min)
- Pregnancy
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A induced moderate hypothermia Induced moderate hypothermia (32-33 C)
- Primary Outcome Measures
Name Time Method 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. 3 month post injury
- Secondary Outcome Measures
Name Time Method To determine the effect of HYPO 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 To determine the effect of HYPO after severe TBI in children of different age ranges (< 6y; 6-<16y; and 16-<18y) on mortality and 6 and 12 months functional and neurocognitive outcomes. 3, 6 and 12 months post injury To determine the effect of HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure (CPP). 7 days post injury
Trial Locations
- Locations (30)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh/Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas, Southwestern
🇺🇸Dallas, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
Princess Margaret Hospital for Children
🇦🇺Subiaco, Perth, Western Australia, Australia
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Washington
🇺🇸Seattle, Washington, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Royal Children's Hospital Melbourne
🇦🇺Parkville, Victoria, Australia
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Royal Children's Hospital, Brisbane
🇦🇺Brisbane, Queensland, Australia
Mater Children's Hospital
🇦🇺Brisbane, Queensland, Australia
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Cohen's Children's Hospital
🇺🇸New Hyde Park, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Sydney Children's Hospital, Randwick
🇦🇺Sydney, New South Wales, Australia
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Children's Youth and Women's Health Service
🇦🇺North Adelaide, South Australia, Australia
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
University of Cape Town
🇿🇦Rondebosch, Cape Town, South Africa
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Institute of Child Health, Univ. College London & Great Ormond
🇬🇧Bloomsbury, London, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, West Midlands, United Kingdom