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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Sponsor: University of Michigan
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.
Key Details
Gender
All
Age Range
2 Days - 17 Years
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2022-08-05
Completion Date
2028-03-31
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
Therapeutic Hypothermia
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.
Locations (59)
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
Johns Hopkins All Children's Hospital
St. Petersburg, 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
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, 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
Montefiore Einstein Hospital Moses Campus
The Bronx, 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
Children's Memorial Hermann Hospital
Houston, 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
Townsville University Hospital
Douglas, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Women's and Children's Hospital
North Adelaide, South Australia, 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