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Hypothermia in Children After Trauma

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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
History of Changes
  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:

U.S. FDA Resources

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

  Show 30 Study Locations
Sponsors and Collaborators
Phoenix Children's Hospital
National Institutes of Health (NIH)
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
Body Temperature Changes
Signs and Symptoms
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013