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Cooling time trial for kids after heart stopping: could longer be better?

NCT ID NCT05376267

Disease control Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 7 times

Summary

This study tests different lengths of body cooling in children who remain unconscious after a cardiac arrest outside the hospital. The goal is to see if longer cooling helps protect the brain and improve recovery. The trial will enroll 900 children and follow them for one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Therapeutic hypothermia (controlled body cooling)
What this could lead to
If it works, this could identify the optimal cooling duration to improve brain function and survival in children after cardiac arrest.
What could go wrong
This is an early-phase trial with no definitive results yet. The optimal duration may not improve outcomes, and longer cooling could carry risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 days to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia cardiac arrest Coma Hypothermia Out-of-Hospital Cardiac Arrest perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac arrest, out-of-hospital Hypothermia, induced Hypoxia-ischemia, brain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    61 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • American Family Children's Hospital

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Ann & Robert Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Banner University Medical Center - Tucson

    COMPLETED

    Tucson, Arizona, 85719, United States

  • Birmingham Children's Hospital, United Kingdom

    RECRUITING

    Birmingham, United Kingdom

  • Bristol Royal Hospital for Children

    RECRUITING

    Bristol, Bristol, BS2 8BJ, United Kingdom

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital of Illinois

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868-4203, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh (UPMC)

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Medical Center of Dallas

    RECRUITING

    Dallas, Texas, 75235, United States

  • Children's Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Cincinnati Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cohen Children's Medical Center of NY / Northwell Health

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • Comer Children's Hospital, University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Evelina London Children's Hospital

    RECRUITING

    London, London, SE17EH, United Kingdom

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, Australia

  • J.W. Ruby Memorial Hospital

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins Medicine Children's Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • MassGeneral Hospital for Children

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical City Children's Hospital

    RECRUITING

    Dallas, Texas, 75230, United States

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

    RECRUITING

    Long Beach, California, 90806-1701, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Montefiore Einstein Hospital Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Mount Sinai Icahn / Kravis Children's Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Ohio State University / Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Oregon Health & Science University Doernbecher Children's Hospital

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn State University / Penn State Children's Hospital

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, Australia

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Primary Children's Hospital, University of Utah School of Medicine

    WITHDRAWN

    Salt Lake City, Utah, 84108, United States

  • Queensland Children's Hospital

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Riley Children's Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Royal Children's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Stanford

    RECRUITING

    Santa Clara, California, 95050, United States

  • Starship Children's Hospital

    RECRUITING

    Grafton, Auckland, 1142, New Zealand

  • Texas Children's Hospital, Baylor

    RECRUITING

    Houston, Texas, 77030, United States

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, Canada

  • The University of North Carolina at Chapel Hill

    RECRUITING

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

  • The University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Townsville University Hospital

    RECRUITING

    Douglas, Queensland, Australia

  • University of Alabama at Birmingham / Children's of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Buffalo / Oishei Children's Hospital

    RECRUITING

    Buffalo, New York, 14203, United States

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

    RECRUITING

    Oakland, California, 94609, United States

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

    RECRUITING

    San Francisco, California, 94158, United States

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

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, Davis

    RECRUITING

    Sacramento, California, 95817, United States

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

    RECRUITING

    Gainesville, Florida, 32610-0296, United States

  • University of Iowa, Carver College of Medicine

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Maryland Children's Hospital

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33124, United States

  • University of Michigan CS Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota Fairview Masonic Children's Hospital

    WITHDRAWN

    Minneapolis, Minnesota, 55454, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642-8667, United States

  • University of Tennesses Health Center / Le Bonheur Children's

    RECRUITING

    Memphis, Tennessee, 38104, United States

  • Washington University / St. Louis Children's Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Women's and Children's Hospital

    RECRUITING

    North Adelaide, South Australia, 5006, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.