Hypothermia in Children After Trauma

Traumatic Brain Injury Clinical Trial

Official title:

Pediatric Traumatic Brain Injury Consortium: Hypothermia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00222742
• Other study ID #: 1R01-NS052478-01
• Secondary ID: 1R01NS052478-01
• Status: Terminated
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: July 10, 2012
• Start date: November 2007
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hypothermia
• Traumatic Brain Injury

Intervention

Procedure:
• induced moderate hypothermia
Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.

Locations

Country	Name	City	State
Australia	Mater Children's Hospital	Brisbane	Queensland
Australia	Royal Children's Hospital, Brisbane	Brisbane	Queensland
Australia	Children's Youth and Women's Health Service	North Adelaide	South Australia
Australia	Royal Children's Hospital Melbourne	Parkville	Victoria
Australia	Princess Margaret Hospital for Children	Subiaco, Perth	Western Australia
Australia	Sydney Children's Hospital, Randwick	Sydney	New South Wales
Australia	Children's Hospital at Westmead	Westmead	New South Wales
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
New Zealand	Starship Children's Hospital	Auckland
South Africa	University of Cape Town	Rondebosch	Cape Town
United Kingdom	Birmingham Children's Hospital	Birmingham	West Midlands
United Kingdom	Institute of Child Health, Univ. College London & Great Ormond	Bloomsbury	London
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas, Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	University of Miami	Miami	Florida
United States	Cohen's Children's Hospital	New Hyde Park	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Childrens Hospital	Phoenix	Arizona
United States	University of Pittsburgh/Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	University of California, Davis Medical Center	Sacramento	California
United States	University of Washington	Seattle	Washington
United States	Washington University	St. Louis	Missouri
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Phoenix Children's Hospital	National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No