Actively Recruiting
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Led by University of Michigan · Updated on 2026-06-05
900
Participants Needed
61
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how different lengths of cooling treatment affect brain recovery in children who are comatose after surviving a cardiac arrest outside the hospital. The trial aims to find the best duration of induced hypothermia to protect the brain and improve neurobehavioral outcomes. They believe that longer cooling might help more children recover better or improve recovery in those already doing well. Participants will be randomly assigned to one of several groups with varying cooling durations: some will be kept at normal temperature for five days, while others will be cooled to 33°C for 12 to 96 hours, followed by a slow rewarming period of about 16 hours, then maintained at normal temperature until the fifth day. This study uses a controlled temperature device to deliver the therapeutic hypothermia. During the study, children will be closely monitored, including assessments of their behavior and brain function at 12 months after their cardiac arrest. Researchers will measure outcomes like adaptive behavior scores, brain performance changes, survival rates, and overall recovery. Consent is required from a legal guardian, and participants must be treated and observed carefully for safety and effectiveness throughout the trial period, which follows them up to one year after their initial treatment.
CONDITIONS
Brief Title
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 days to under 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
- Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
- Definitive temperature control device initiated
- Randomization within 6 hours of Return of Spontaneous Circulation
- Informed consent from legally authorized representative including intent to maintain life support for 120 hours
You will not qualify if you...
- Glasgow Coma Motor Score of 6
- Legally authorized representative does not speak English or Spanish
- Duration of Cardiopulmonary Resuscitation over 60 minutes
- Severe hemodynamic instability with continuous high-dose epinephrine or norepinephrine or initiation of extracorporeal membrane oxygenation
- Pre-existing severe neurodevelopmental deficits or progressive degenerative encephalopathy
- Pre-existing terminal illness with unlikely survival 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 preventing 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 this trial
- Prisoner status
- Chronic hypothermia
- New post-cardiac arrest diabetes insipidus
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 hours after return of spontaneous circulation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 5 days
Participants receive therapeutic hypothermia with controlled rewarming according to their assigned cooling duration, followed by maintenance of normal body temperature until the end of the 5th day.
Continuous monitoring during treatment period
Duration - 12 months
Participants are monitored for outcomes including adaptive behavior, neurological function, and survival up to 12 months after cardiac arrest.
Follow-up visits at baseline and 12 months after cardiac arrest
Trial Site Locations
Total: 61 locations
1
University of Alabama at Birmingham / Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Active, Not Recruiting
4
Memorial Health - Miller Children's and Women's Hospital of Long Beach
Long Beach, California, United States, 90806-1701
Actively Recruiting
5
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
6
University of California Los Angeles (UCLA) Mattel Children's Hospital
Los Angeles, California, United States, 90095
Actively Recruiting
7
University of California - Oakland / UCSF Benoiff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
8
Children's Hospital of Orange County
Orange, California, United States, 92868-4203
Actively Recruiting
9
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
10
University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
11
Stanford
Santa Clara, California, United States, 95050
Actively Recruiting
12
University of Florida (UF) Health Shands Children's Hospital
Gainesville, Florida, United States, 32610-0296
Actively Recruiting
13
University of Miami
Miami, Florida, United States, 33124
Actively Recruiting
14
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
15
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
16
Comer Children's Hospital, University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Children's Hospital of Illinois
Peoria, Illinois, United States, 61637
Actively Recruiting
18
Riley Children's Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
19
University of Iowa, Carver College of Medicine
Iowa City, Iowa, United States, 52242
Actively Recruiting
20
University of Maryland Children's Hospital
Baltimore, Maryland, United States, 21201
Actively Recruiting
21
Johns Hopkins Medicine Children's Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
22
MassGeneral Hospital for Children
Boston, Massachusetts, United States, 02114
Actively Recruiting
23
University of Michigan CS Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
24
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
25
University of Minnesota Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55454
Withdrawn
26
Washington University / St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
27
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
28
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
29
University of Buffalo / Oishei Children's Hospital
Buffalo, New York, United States, 14203
Actively Recruiting
30
Cohen Children's Medical Center of NY / Northwell Health
New Hyde Park, New York, United States, 11040
Actively Recruiting
31
Mount Sinai Icahn / Kravis Children's Hospital
New York, New York, United States, 10029
Actively Recruiting
32
University of Rochester Medical Center
Rochester, New York, United States, 14642-8667
Actively Recruiting
33
Montefiore Einstein Hospital Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
34
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7220
Actively Recruiting
35
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
36
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
37
Ohio State University / Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
38
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
39
Oregon Health & Science University Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
Actively Recruiting
40
Penn State University / Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
41
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
42
Children's Hospital of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
43
University of Tennesses Health Center / Le Bonheur Children's
Memphis, Tennessee, United States, 38104
Actively Recruiting
44
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
45
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Actively Recruiting
46
Texas Children's Hospital, Baylor
Houston, Texas, United States, 77030
Actively Recruiting
47
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
48
Primary Children's Hospital, University of Utah School of Medicine
Salt Lake City, Utah, United States, 84108
Withdrawn
49
American Family Children's Hospital
Madison, Wisconsin, United States, 53705
Actively Recruiting
50
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
51
Queensland Children's Hospital
Brisbane, Queensland, Australia, 4101
Actively Recruiting
52
Townsville University Hospital
Douglas, Queensland, Australia
Actively Recruiting
53
Gold Coast University Hospital
Southport, Queensland, Australia
Actively Recruiting
54
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
55
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
56
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
57
Perth Children's Hospital
Nedlands, Western Australia, Australia
Actively Recruiting
58
The Hospital for Sick Children
Toronto, Ontario, Canada
Actively Recruiting
59
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1142
Actively Recruiting
60
Birmingham Children's Hospital, United Kingdom
Birmingham, United Kingdom
Actively Recruiting
61
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
Research Team
F
Frank Moler, MD
M
Moni Weber
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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