An interventional study of Therapeutic Hypothermia in Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced and Hypoxia-Ischemia, Brain, sponsored by University of Michigan. Recruiting at 65 sites in 5 countries. Open to participants aged 2 Days to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.
This study's planned enrollment of 900 is above the median of 218 across 179 interventional studies indexed under Out-of-Hospital Cardiac Arrest.
Browse Out-of-Hospital Cardiac Arrest studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be kept at a normal temperature for the whole 5 days.
Device: Therapeutic Hypothermia
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
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
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
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
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
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
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
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
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.
Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation
The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.
Time frame: 12 months after out-of-hospital cardiac arrest
Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline
The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.
Time frame: Baseline and 12 months after cardiac arrest
Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months
The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.
Time frame: 12 months after cardiac arrest
Survival at 12 months
Time frame: 12 months after cardiac arrest
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data will be stored in the NHLBI data repository after trial completion.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 1 year after publication on main outcome results paper
Access criteria: Data use agreement with the appropriate NHLBI repository
Started Aug 2022 (actual). Primary completion is estimated for Mar 2028, 67 months after the start.
Of 93 non-industry interventional studies with no phase under Out-of-Hospital Cardiac Arrest, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 67 months is above that.
Counting every sponsor, half of 95 studies reached it within 34 months; a quarter within 19 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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