Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
- Conditions
- Hypoxia-Ischemia, BrainCardiac Arrest, Out-Of-HospitalHypothermia, Induced
- Interventions
- Device: Therapeutic Hypothermia
- Registration Number
- NCT05376267
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cooling 60 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 60 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 48 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 48 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 24 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 24 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 36 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 36 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 72 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 72 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 84 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 84 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 0 hours Therapeutic Hypothermia Participants will be kept at a normal temperature for the whole 5 days. Cooling 12 hours Therapeutic Hypothermia The participant will be cooled to 33°Celsius (C) for 12 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 18 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 18 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day. Cooling 96 hours Therapeutic Hypothermia The participant will be cooled to 33°C for 96 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
- Primary Outcome Measures
Name Time Method Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation 12 months after out-of-hospital cardiac arrest 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.
- Secondary Outcome Measures
Name Time Method Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months 12 months after cardiac arrest 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.
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline Baseline and 12 months after cardiac arrest 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.
Survival at 12 months 12 months after cardiac arrest
Trial Locations
- Locations (53)
University of Alabama at Birmingham / Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Banner University Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Memorial Health - Miller Children's and Women's Hospital of Long Beach
🇺🇸Long Beach, California, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
University of California Los Angeles (UCLA) Mattel Children's Hospital
🇺🇸Los Angeles, California, United States
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
🇺🇸Oakland, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
🇺🇸San Francisco, California, United States
Stanford
🇺🇸Santa Clara, California, United States
University of Florida (UF) Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Ann & Robert Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Comer Children's Hospital, University of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Illinois
🇺🇸Peoria, Illinois, United States
Riley Children's Health
🇺🇸Indianapolis, Indiana, United States
University of Iowa, Carver College of Medicine
🇺🇸Iowa City, Iowa, United States
University of Maryland Children's Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Medicine Children's Center
🇺🇸Baltimore, Maryland, United States
MassGeneral Hospital for Children
🇺🇸Boston, Massachusetts, United States
University of Michigan CS Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
University of Minnesota Fairview Masonic Children's Hospital
🇺🇸Minneapolis, Minnesota, United States
Washington University / St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
University of Buffalo / Oishei Children's Hospital
🇺🇸Buffalo, New York, United States
Cohen Children's Medical Center of NY / Northwell Health
🇺🇸New Hyde Park, New York, United States
Mount Sinai Icahn / Kravis Children's Hospital
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Ohio State University / Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Dayton Children's Hospital
🇺🇸Dayton, Ohio, United States
Oregon Health & Science University Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Penn State University / Penn State Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
University of Tennesses Health Center / Le Bonheur Children's
🇺🇸Memphis, Tennessee, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Texas Children's Hospital, Baylor
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Primary Children's Hospital, University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
American Family Children's Hospital
🇺🇸Madison, Wisconsin, United States
Children's Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Queensland Children's Hospital
🇦🇺Brisbane, Queensland, Australia
Gold Coast University Hospital
🇦🇺Southport, Queensland, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Perth Children's Hospital
🇦🇺Nedlands, Western Australia, Australia
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Starship Children's Hospital
🇳🇿Grafton, Auckland, New Zealand
Birmingham Children's Hospital, United Kingdom
🇬🇧Birmingham, United Kingdom