Recruiting

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

Sponsor:

University of Michigan

Code:

NCT05376267

Conditions

Cardiac Arrest, Out-Of-Hospital

Hypothermia, Induced

Hypoxia-Ischemia, Brain

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Therapeutic Hypothermia

Study Details

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.

Conditions

Cardiac Arrest, Out-Of-Hospital

Hypothermia, Induced

Hypoxia-Ischemia, Brain

Study ID

NCT05376267

Start date

Aug 5, 2022

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cooling 0 hours

Participants will be kept at a normal temperature for the whole 5 days.

experimental: Cooling 12 hours

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.

experimental: Cooling 18 hours

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.

experimental: Cooling 24 hours

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.

experimental: Cooling 36 hours

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.

experimental: Cooling 48 hours

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.

experimental: Cooling 60 hours

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.

experimental: Cooling 72 hours

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.

experimental: Cooling 84 hours

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.

experimental: Cooling 96 hours

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.

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.

Primary outcome measure

Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation [ Time Frame: 12 months after out-of-hospital cardiac arrest ]

Central Contacts and Locations

Central contacts

Frank Moler, MD

734-764-5302 fmoler@umich.edu

Moni Weber

734-232-4803 monij@umich.edu

Locations

University of Alabama at Birmingham / Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Michele Kong, MD

205-638-9387 mkong@uabmc.edu

Principal Investigator:

Michele Kong, MD

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

F. Anthony Willyerd, MD

602-471-5064 fwillyerd@phoenixchildrens.com

Principal Investigator:

F. Anthony Willyerd, MD

Memorial Health - Miller Children's and Women's Hospital of Long Beach

Recruiting

Long Beach, California, United States, 90806-1701

Contacts

Christopher Babbitt, MD

562-933-8743 CBabbitt@memorialcare.org

Principal Investigator:

Christopher Babbitt, MD

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Bradley De Souza, MD

323-361-8202 bdesouza@chla.usc.edu

David Baron, MS

323-361-6329 dbaron@chla.usc.edu

University of California Los Angeles (UCLA) Mattel Children's Hospital

Recruiting

Los Angeles, California, United States, 90095

Contacts

Anil Sapru, MD

asapru@mednet.ucla.edu

Principal Investigator:

Anil Sapru, MD

University of California - Oakland / UCSF Benoiff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Natalie Cvijanovich, MD

(510) 428-3302

Principal Investigator:

Natalie Cvijanovich, MD

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868-4203

Contacts

Adam Schwarz, MD

714-509-8620 aschwarz@choc.org

Principal Investigator:

Adam Schwarz, MD

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Heather Siefkes, MD

916-734-7620 hsiefkes@ucdavis.edu

Principal Investigator:

Heather Siefkes, MD

University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Patrick McQuillen, MD

patrick.mcquillen@ucsf.edu

Principal Investigator:

Patrick McQuillen, MD

Stanford

Recruiting

Santa Clara, California, United States, 95050

Contacts

Tim Cornell, MD

tcornell@stanford.edu

Principal Investigator:

Tim Cornell, MD

University of Florida (UF) Health Shands Children's Hospital

Recruiting

Gainesville, Florida, United States, 32610-0296

Contacts

Shruthi Mahadevaiah, MD

313-318-7383 smahadevaiah@ufl.edu

Principal Investigator:

Shruthi Mahadevaiah, MD

University of Miami

Recruiting

Miami, Florida, United States, 33124

Contacts

Jennifer Munoz Pareja, MD

jcm457@med.miami.edu

Principal Investigator:

Jennifer Munoz Pareja, MD

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Anthony Sochet, MD., M.Sc.

727-767-4343 asochet1@jh.edu

Principal Investigator:

Nathan Dean, MD

Ann & Robert Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Craig Smith, MD

312-227-4800 CMSmith@luriechildrens.org

Principal Investigator:

Craig Smith, MD

Comer Children's Hospital, University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Casey Stulce, MD

7738343837 cstulce@bsd.uchicago.edu

Principal Investigator:

Casey Stulce, MD

Children's Hospital of Illinois

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Sandeep Tripathi, MD

309-624-0719 sandeept@uic.edu

Principal Investigator:

Sandeep Tripathi, MD

Riley Children's Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Matthew Yuknis, MD

317-944-3345 myuknis@iupui.edu

Principal Investigator:

Matthew Yuknis, MD

University of Iowa, Carver College of Medicine

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kari Wellnitz, MD

kari-wellnitz@uiowa.edu

Principal Investigator:

Kari Wellnitz, MD

University of Maryland Children's Hospital

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Siddhartha Dante, MD

abhutta@som.umaryland.edu

Principal Investigator:

Siddhartha Dante, MD

Johns Hopkins Medicine Children's Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Caitlin O'Brien, MD, MPH

720-635-1730 Cobrie19@jhmi.edu

Principal Investigator:

Caitlin O'Brien, MD, MPH

MassGeneral Hospital for Children

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sarah MD Murphy, MD

617-724-4380 samurphy@mgh.harvard.edu

Principal Investigator:

Sarah Murphy, MD

University of Michigan CS Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Ryan Barbaro, MD

barbaror@umich.edu

Principal Investigator:

Ryan Barbaro, MD

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Kathleen Meert, MD

313-745-5870 meert1kl@cmich.edu

Principal Investigator:

Kathleen Meert, MD

Washington University / St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stuart Friess, MD

friess@wustl.edu

Principal Investigator:

Stuart Friess, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Alyson Baker, MD MS

402-955-7257 alybaker@childrensnebraska.org

Principal Investigator:

Alyson Baker, MD MS

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Ilana Harwayne-Gidansky, MD

5182625127 harwayi@amc.edu

Principal Investigator:

Ilana Harwayne-Gidansky, MD

University of Buffalo / Oishei Children's Hospital

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ryan Breuer, MD

ryanbrue@buffalo.edu

Principal Investigator:

Ryan Breuer, MD

Cohen Children's Medical Center of NY / Northwell Health

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Taylor Nickerson, MD

(718) 470-3668 tnickerson@northwell.edu

Principal Investigator:

Todd Sweberg, MD

Mount Sinai Icahn / Kravis Children's Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Shubhi Kaushik, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642-8667

Contacts

Jake Deines, MD

585-273-5269 Jake_deines@urmc.rochester.edu

Principal Investigator:

Jake Deines, MD

Montefiore Einstein Hospital Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Alvaro J Coronado Munoz, MD

7187412432 acoronadom@montefiore.org

The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-7220

Contacts

Kieran Leong, DO

919-966-7495 Kieran_Leong@med.unc.edu

Principal Investigator:

Benny Joyner, MD, MPH

Children's Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308

Contacts

Ryan Nofziger, MD

330-543-8639 mofziger@akronchildrens.org

Chris Page-Goertz, MD

330-543-8639 cpage-goertz@akronchildrens.org

Principal Investigator:

Ryan Nofziger, MD

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Ranjit Chima, MD

ranjit.chima@cchmc.org

Principal Investigator:

Ranjit Chima, MD

Ohio State University / Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Marlina Lovett, MD

marlina.lovett@nationwidechildrens.org

Principal Investigator:

Marlina Lovett, MD

Dayton Children's Hospital

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Hemanth Lingadevaru, MD

9376415168 lingadevaruh@childrensdayton.org

Principal Investigator:

Hemanth Lingadevaru, MD

Oregon Health & Science University Doernbecher Children's Hospital

Recruiting

Portland, Oregon, United States, 97239

Contacts

Mohamud Daya, MD, MS

503-494-7248 dayam@ohsu.edu

Serena Kelly, MS

503-789-4580 phromsiv@ohsu.edu

Principal Investigator:

Serena Kelly, MS

Penn State University / Penn State Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Neal Thomas, MD

nthomas@pennstatehealth.psu.edu

Principal Investigator:

Neal Thomas, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Matthew Kirschen, MD

kirschenm@chop.edu

Principal Investigator:

Matthew Kirschen, MD

Children's Hospital of Pittsburgh (UPMC)

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Ericka Fink, MD

finkel@ccm.upmc.edu

Principal Investigator:

Ericka Fink, MD

University of Tennesses Health Center / Le Bonheur Children's

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Laurel Metzler, MD

lmetzler@uthsc.edu

Principal Investigator:

Laruel Metzler, MD

Children's Medical Center of Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Joshua Wolovits, MD

joshua.wolovits@utsouthwestern.edu

Principal Investigator:

Joshua Wolovits, MD

Children's Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Thao Nguyen, MD

832 512 1595 Thao.L.Nguyen@uth.tmc.edu

Texas Children's Hospital, Baylor

Recruiting

Houston, Texas, United States, 77030

Contacts

Jennifer Erklauer, MD

jclee@bcm.edu

Principal Investigator:

Jennifer Erklauer, MD

The University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Theodore Wu, MD

210-567-5816 wut@uthscsa.edu

Principal Investigator:

Theodore Wu, MD

J.W. Ruby Memorial Hospital

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Ryan A Nofziger, MD, MBA

304-293-1217 Ryan.Nofziger@hsc.wvu.edu

Principal Investigator:

Ryan A Nofziger, MD, MBA

American Family Children's Hospital

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Peter Ferrazzano, MD

(608) 265-4839 ferrazzano@pediatrics.wisc.edu

Principal Investigator:

Peter Ferrazzano, MD

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Binod Balakrishnan, MD

414-266-3360 bbalakris@mcw.edu

Principal Investigator:

Binod Balakrishnan, MD

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Anne-Marie Guerguerian, MD, PhD

416-813-7654 anne-marie.guerguerian@sickkids.ca

Principal Investigator:

Anne-Marie Guerguerian, MD, PhD

More Information

Sponsor

University of Michigan

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

Bayesian Adaptive Clinical Trial
Hypothermia, therapeutic
Coma
Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-09-02.