This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
900
Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.
University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama, United States
RECRUITINGPhoenix Children's Hospital
Phoenix, Arizona, United States
RECRUITINGBanner University Medical Center - Tucson
Tucson, Arizona, United States
RECRUITINGMemorial Health - Miller Children's and Women's Hospital of Long Beach
Long Beach, California, United States
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.
Time frame: 12 months after out-of-hospital cardiac arrest
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.
Time frame: Baseline and 12 months after cardiac arrest
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.
Time frame: 12 months after cardiac arrest
Survival at 12 months
Time frame: 12 months after cardiac arrest
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Children's Hospital of Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles (UCLA) Mattel Children's Hospital
Los Angeles, California, United States
RECRUITINGUniversity of California - Oakland / UCSF Benoiff Children's Hospital Oakland
Oakland, California, United States
RECRUITINGChildren's Hospital of Orange County
Orange, California, United States
RECRUITINGUniversity of California, Davis
Sacramento, California, United States
RECRUITINGUniversity of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
San Francisco, California, United States
RECRUITING...and 46 more locations