Hypothermia in Children After Trauma

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT00222742
First received: September 16, 2005
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Traumatic Brain Injury
Procedure: induced moderate hypothermia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Traumatic Brain Injury Consortium: Hypothermia

Resource links provided by NLM:


Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 month post injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: at 6 and 12 months post injury ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3, 6 and 12 months post injury ] [ Designated as safety issue: No ]
  • To determine the effect of HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure (CPP). [ Time Frame: 7 days post injury ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2007
Study Completion Date: March 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Induced moderate hypothermia (32-33 C)
Procedure: induced moderate hypothermia
Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.

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).
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a GCS </= 8
  2. Glasgow Motor Score < 6
  3. Closed head injury
  4. Age 0 < 18 y

Exclusion Criteria

  1. Unavailable to initiate cooling within 6 hours of injury
  2. Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function
  3. Normal initial CT scan (No blood, fracture, swelling, and/or shift)
  4. Penetrating brain injury
  5. No known mechanism of injury
  6. Unknown time of injury
  7. Uncorrectable coagulopathy (PT/PTT > 16/40 sec, INR > 1.7)
  8. Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min)
  9. Documented Hypoxic episode (O2 saturation < 94% for > 30 min)
  10. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222742

  Hide Study Locations
Locations
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Cohen's Children's Hospital
New Hyde Park, New York, United States, 11040
Weill Cornell Medical Center
New York, New York, United States, 10950
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 47229-3039
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh/Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas, Southwestern
Dallas, Texas, United States, 75235
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Australia, New South Wales
Sydney Children's Hospital, Randwick
Sydney, New South Wales, Australia, 2031
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Mater Children's Hospital
Brisbane, Queensland, Australia, 4101
Royal Children's Hospital, Brisbane
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Children's Youth and Women's Health Service
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Subiaco, Perth, Western Australia, Australia, 6008
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G2B7
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V4A 5X3
New Zealand
Starship Children's Hospital
Auckland, New Zealand, 1023
South Africa
University of Cape Town
Rondebosch, Cape Town, South Africa, 7700
United Kingdom
Institute of Child Health, Univ. College London & Great Ormond
Bloomsbury, London, United Kingdom, WC1N 3JH
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom, UK B4 6NH
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: P. David Adelson, MD Phoenix Children's Hospital
  More Information

No publications provided

Responsible Party: Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00222742     History of Changes
Other Study ID Numbers: 1R01-NS052478-01, 1R01NS052478-01
Study First Received: September 16, 2005
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:
hypothermia
pediatric TBI

Additional relevant MeSH terms:
Hypothermia
Brain Injuries
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014