Hypothermia in Children After Trauma

July 10, 2012 updated by: Phoenix Children's Hospital

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 month post injury

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 3, 6 and 12 months post injury
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).
Time Frame: 7 days post injury
7 days post injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix Children's Hospital

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: P. David Adelson, MD, Phoenix Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01-NS052478-01
  • 1R01NS052478-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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