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Purpose

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

Eligibility

Eligible Ages
Between 2 Days and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Bayesian Adaptive Design
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
The outcomes assessors will be blinded to the treatment assignment of the participant.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cooling 0 hours 		Participants will be kept at a normal temperature for the whole 5 days.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.
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.
  • Device: 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.

Recruiting Locations

University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama 35233
Contact:
Michele Kong, MD
205-638-9387
mkong@uabmc.edu

Phoenix Children's Hospital
Phoenix, Arizona 85016
Contact:
F. Anthony Willyerd, MD
602-471-5064
fwillyerd@phoenixchildrens.com

Banner University Medical Center - Tucson
Tucson, Arizona 85719
Contact:
Mary Gaspers, MD

Memorial Health - Miller Children's and Women's Hospital of Long Beach
Long Beach, California 90806-1701
Contact:
Christopher Babbitt, MD
562-933-8743
CBabbitt@memorialcare.org

Children's Hospital of Los Angeles
Los Angeles, California 90027
Contact:
Bradley De Souza, MD
323-361-8202
bdesouza@chla.usc.edu

University of California Los Angeles (UCLA) Mattel Children's Hospital
Los Angeles, California 90095
Contact:
Anil Sapru, MD
asapru@mednet.ucla.edu

University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
Oakland, California 94609
Contact:
Natalie Cvijanovich, MD
510-428-3302

Children's Hospital of Orange County
Orange, California 92868-4203
Contact:
Adam Schwarz, MD
714-509-8620
aschwarz@choc.org

University of California, Davis
Sacramento, California 95817
Contact:
Heather Siefkes, MD
916-734-7620
hsiefkes@ucdavis.edu

University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
San Francisco, California 94158
Contact:
Patrick McQuillen, MD
patrick.mcquillen@ucsf.edu

Stanford
Santa Clara, California 95050
Contact:
Tim Cornell, MD
tcornell@stanford.edu

University of Florida (UF) Health Shands Children's Hospital
Gainesville, Florida 32610-0296
Contact:
Shruthi Mahadevaiah, MD
313-318-7383
smahadevaiah@ufl.edu

University of Miami
Miami, Florida 33124
Contact:
Jennifer Munoz Pareja, MD
jcm457@med.miami.edu

Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
Contact:
Craig Smith, MD
312-227-4800
CMSmith@luriechildrens.org

Comer Children's Hospital, University of Chicago
Chicago, Illinois 60637
Contact:
Casey Stulce, MD
773-834-3837
cstulce@bsd.uchicago.edu

Children's Hospital of Illinois
Peoria, Illinois 61637
Contact:
Sandeep Tripathi, MD
309-624-0719
sandeept@uic.edu

Riley Children's Health
Indianapolis, Indiana 46202
Contact:
Matthew Yuknis, MD
317-944-3345
myuknis@iupui.edu

University of Iowa, Carver College of Medicine
Iowa City, Iowa 52242
Contact:
Kari Wellnitz, MD
kari-wellnitz@uiowa.edu

University of Maryland Children's Hospital
Baltimore, Maryland 21201
Contact:
Siddhartha Dante, MD
abhutta@som.umaryland.edu

Johns Hopkins Medicine Children's Center
Baltimore, Maryland 21287
Contact:
Caitlin O'Brien, MD, MPH
720-635-1730
Cobrie19@jhmi.edu

MassGeneral Hospital for Children
Boston, Massachusetts 02114
Contact:
Sarah MD Murphy, MD
617-724-4380
samurphy@mgh.harvard.edu

University of Michigan CS Mott Children's Hospital
Ann Arbor, Michigan 48109
Contact:
Ryan Barbaro, MD
barbaror@umich.edu

Children's Hospital of Michigan
Detroit, Michigan 48201
Contact:
Kathleen Meert, MD
313-745-5870
meert1kl@cmich.edu

Washington University / St. Louis Children's Hospital
Saint Louis, Missouri 63110
Contact:
Stuart Friess, MD
friess@wustl.edu

University of Buffalo / Oishei Children's Hospital
Buffalo, New York 14203
Contact:
Ryan Breuer, MD
ryanbrue@buffalo.edu

Cohen Children's Medical Center of NY / Northwell Health
New Hyde Park, New York 11040
Contact:
Todd Sweberg, MD
718-470-3668
tsweberg@northwell.edu

Mount Sinai Icahn / Kravis Children's Hospital
New York, New York 10029
Contact:
Shubhi Kaushik, MD

University of Rochester Medical Center
Rochester, New York 14642-8667
Contact:
Jake Deines, MD
585-273-5269
Jake_deines@urmc.rochester.edu

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-7220
Contact:
Benny Joyner, MD, MPH
919-966-7495
benny@unc.edu

Children's Hospital Medical Center of Akron
Akron, Ohio 44308
Contact:
Ryan Nofziger, MD
330-543-8639
mofziger@akronchildrens.org

Cincinnati Children's Hospital
Cincinnati, Ohio 45229
Contact:
Ranjit Chima, MD
ranjit.chima@cchmc.org

Ohio State University / Nationwide Children's Hospital
Columbus, Ohio 43205
Contact:
Marlina Lovett, MD
marlina.lovett@nationwidechildrens.org

Dayton Children's Hospital
Dayton, Ohio 45404
Contact:
Hemanth Lingadevaru, MD
937-641-5168
lingadevaruh@childrensdayton.org

Oregon Health & Science University Doernbecher Children's Hospital
Portland, Oregon 97239
Contact:
Mohamud Daya, MD, MS
503-494-7248
dayam@ohsu.edu

Penn State University / Penn State Children's Hospital
Hershey, Pennsylvania 17033
Contact:
Neal Thomas, MD
nthomas@pennstatehealth.psu.edu

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Contact:
Matthew Kirschen, MD
kirschenm@chop.edu

Children's Hospital of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania 15224
Contact:
Ericka Fink, MD
finkel@ccm.upmc.edu

University of Tennesses Health Center / Le Bonheur Children's
Memphis, Tennessee 38104
Contact:
Alexandra Schaller, DO
901-287-5925
aschalle@uthsc.edu

Children's Medical Center of Dallas
Dallas, Texas 75235
Contact:
Joshua Wolovits, MD
joshua.wolovits@utsouthwestern.edu

The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Theodore Wu, MD
210-567-5816
wut@uthscsa.edu

American Family Children's Hospital
Madison, Wisconsin 53705
Contact:
Peter Ferrazzano, MD
608-265-4839
ferrazzano@pediatrics.wisc.edu

Children's Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Binod Balakrishnan, MD
414-266-3360
bbalakris@mcw.edu

More Details

NCT ID
NCT05376267
Status
Recruiting
Sponsor
University of Michigan

Study Contact

Frank Moler, MD
734-764-5302
fmoler@umich.edu

Notice

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