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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Recruiting

Who can join

2 Days – 17 Years · All sexes

Full eligibility criteria
Inclusion criteria:

* Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks
* Chest compressions for at least 2 minutes
* Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
* Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
* Definitive temperature control device initiated
* Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
* Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours

Exclusion criteria:

* Glasgow Coma Motor Score (GCMS) = 6
* LAR does not speak English or Spanish
* Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes
* Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
* Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
* Pre-existing terminal illness, unlikely to survive to one year
* Cardiac arrest associated with brain, thoracic, or abdominal trauma
* Active and refractory severe bleeding prior to randomization
* Extensive burns or skin lesions incompatible with surface cooling
* Planned early withdrawal of life support before 120 hours
* Sickle cell anemia
* Pre-existing cryoglobulinemia
* Non-fatal drowning in ice covered water
* Central nervous system tumor with ongoing chemotherapy
* Previous enrollment in P-ICECAP trial
* Prisoner
* Chronic hypothermia
* New post-cardiac arrest diabetes insipidus
* Pregnancy

About the study

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.

What is being tested

Sponsor: University of Michigan · Participants: 900 · Started: Aug 5, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05376267

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham / Children's of Alabama, Birmingham
ArizonaPhoenix Children's Hospital, Phoenix
CaliforniaMemorial Health - Miller Children's and Women's Hospital of Long Beach, Long Beach
Children's Hospital of Los Angeles, Los Angeles
University of California Los Angeles (UCLA) Mattel Children's Hospital, Los Angeles
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland, Oakland
Children's Hospital of Orange County, Orange
University of California, Davis, Sacramento
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco, San Francisco
Stanford, Santa Clara
FloridaUniversity of Florida (UF) Health Shands Children's Hospital, Gainesville
University of Miami, Miami
Johns Hopkins All Children's Hospital, St. Petersburg
IllinoisAnn & Robert Lurie Children's Hospital of Chicago, Chicago
Comer Children's Hospital, University of Chicago, Chicago
Children's Hospital of Illinois, Peoria
IndianaRiley Children's Health, Indianapolis
IowaUniversity of Iowa, Carver College of Medicine, Iowa City
MarylandJohns Hopkins Medicine Children's Center, Baltimore
University of Maryland Children's Hospital, Baltimore
MassachusettsMassGeneral Hospital for Children, Boston
MichiganUniversity of Michigan CS Mott Children's Hospital, Ann Arbor
Children's Hospital of Michigan, Detroit
MissouriWashington University / St. Louis Children's Hospital, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New YorkAlbany Medical Center, Albany
University of Buffalo / Oishei Children's Hospital, Buffalo
Cohen Children's Medical Center of NY / Northwell Health, New Hyde Park
Mount Sinai Icahn / Kravis Children's Hospital, New York
University of Rochester Medical Center, Rochester
Montefiore Einstein Hospital Moses Campus, The Bronx
North CarolinaThe University of North Carolina at Chapel Hill, Chapel Hill
OhioChildren's Hospital Medical Center of Akron, Akron
Cincinnati Children's Hospital, Cincinnati
Ohio State University / Nationwide Children's Hospital, Columbus
Dayton Children's Hospital, Dayton
OregonOregon Health & Science University Doernbecher Children's Hospital, Portland
PennsylvaniaPenn State University / Penn State Children's Hospital, Hershey
Children's Hospital of Philadelphia, Philadelphia
Children's Hospital of Pittsburgh (UPMC), Pittsburgh
TennesseeUniversity of Tennesses Health Center / Le Bonheur Children's, Memphis
TexasChildren's Medical Center of Dallas, Dallas
Medical City Children's Hospital, Dallas
Children's Memorial Hermann Hospital, Houston
Texas Children's Hospital, Baylor, Houston
The University of Texas Health Science Center at San Antonio, San Antonio
West VirginiaJ.W. Ruby Memorial Hospital, Morgantown
WisconsinAmerican Family Children's Hospital, Madison
Children's Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.