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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00222742 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Hypothermia in Children After Trauma
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Scientific title:
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Pediatric Traumatic Brain Injury Consortium: Hypothermia |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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90 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00222742 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Canada
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New Zealand
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South Africa
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United Kingdom
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United States
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Contacts
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Name:
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P. David Adelson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with a GCS
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
Age minimum:
N/A
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Traumatic Brain Injury
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Intervention(s)
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Procedure: induced moderate hypothermia
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Primary Outcome(s)
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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.
[Time Frame: 3 month post injury]
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Secondary Outcome(s)
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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]
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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]
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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]
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Secondary ID(s)
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1R01-NS052478-01
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1R01NS052478-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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