Cooling Treatment for Pediatric Cardiac Arrest Recovery
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Recruiting
N/A
Interventional Study
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 2 Days – 17
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 900 (estimated)
- Sponsor
- University of Michigan · Other
Who this trial is looking for
This trial is looking for children aged 2 days to under 18 years who have undergone cardiac arrest outside of a hospital. Participants will receive a cooling treatment for a specific period to see if it helps improve their recovery after the event.
Are You a Good Fit for This Trial?
You may be able to join if
- I am aged 2 days to under 18 years.
- I have had chest compressions for at least 2 minutes.
- I am in a coma or have brain dysfunction after cardiac arrest.
- I need to be on a breathing machine.
- I have a cooling device started.
- I can join the trial within 6 hours after my heart starts beating again.
- My family has given consent to keep life support for 120 hours.
You may not be able to join if
- I have a Glasgow Coma Motor Score of 6.
- My family does not speak English or Spanish.
- I received CPR for more than 60 minutes.
- I have serious heart or blood pressure problems requiring specific medications.
- I have major brain injuries or diseases before my cardiac arrest.
- I have an illness that will not allow me to live for more than a year.
- I had a major injury during the cardiac arrest.
- I have severe bleeding that won't stop before the trial begins.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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 ca…
Trial Locations
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Eligibility Criteria
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 t…
Contacts