Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
90 participants
INTERVENTIONAL
2007-11-30
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Induced moderate hypothermia (32-33 C)
induced moderate hypothermia
Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
induced moderate hypothermia
Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Glasgow Motor Score \< 6
3. Closed head injury
4. Age 0 \< 18 y
Exclusion Criteria
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
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Phoenix Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
P. David Adelson, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix Childrens Hospital
Phoenix, Arizona, United States
University of California, Davis Medical Center
Sacramento, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Cohen's Children's Hospital
New Hyde Park, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh/Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas, Southwestern
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Sydney Children's Hospital, Randwick
Sydney, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital, Brisbane
Brisbane, Queensland, Australia
Mater Children's Hospital
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
Stollery Children's Hospital
Edmonton, Alberta, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Starship Children's Hospital
Auckland, , New Zealand
University of Cape Town
Rondebosch, Cape Town, South Africa
Institute of Child Health, Univ. College London & Great Ormond
Bloomsbury, London, United Kingdom
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Meinert E, Bell MJ, Buttram S, Kochanek PM, Balasubramani GK, Wisniewski SR, Adelson PD; Pediatric Traumatic Brain Injury Consortium: Hypothermia Investigators. Initiating Nutritional Support Before 72 Hours Is Associated With Favorable Outcome After Severe Traumatic Brain Injury in Children: A Secondary Analysis of a Randomized, Controlled Trial of Therapeutic Hypothermia. Pediatr Crit Care Med. 2018 Apr;19(4):345-352. doi: 10.1097/PCC.0000000000001471.
Adelson PD, Wisniewski SR, Beca J, Brown SD, Bell M, Muizelaar JP, Okada P, Beers SR, Balasubramani GK, Hirtz D; Paediatric Traumatic Brain Injury Consortium. Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial. Lancet Neurol. 2013 Jun;12(6):546-53. doi: 10.1016/S1474-4422(13)70077-2. Epub 2013 May 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1R01NS052478-01
Identifier Type: -
Identifier Source: secondary_id
1R01-NS052478-01
Identifier Type: -
Identifier Source: org_study_id