Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorUniversity of Michigan
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 categorized as having a good outcome.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Therapeutic Hypothermia
Treatment groups
900 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Michigan
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Kennedy Krieger Institute, Baltimore, MD
Collaborator
Source ClinicalTrials.gov