Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Overview

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 who attain a good neurobehavioral recovery or result in better recovery among those already categorized as having a good outcome.

Population of the study: Comatose pediatric (defined as 2 days to <18 years) survivors of out-of-hospital cardiac arrest (OCHA) who have already started targeted temperature management using a definitive temperature-control device

Intervention:
Device: therapeutic hypothermia

The intervention will involve a random allocation to the duration of cooling — ranging from 0 to 96 hours — using FDA-cleared, surface-cooling devices.

Control: Temperature control is part of standard intensive care, but the choice of temperature at which a child is maintained, as well as the duration of this maintenance, varies by local practice in different hospitals and by the preferences of other doctors. National practice guidelines for standard critical care recommend maintaining temperatures between 33-37°C (91.4-98.6°F) for approximately 3-5 days.

Outcome: The primary outcome is titled the Vineland Adaptive Behavior Scales – Third Edition (VABS-3) Mortality Composite Score. It is defined as the VABS-3 age-standardized neurobehavioral function measure assessed at 1 year after OHCA in survivors and adjusted for mortality (death score = 0).

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Trial Information

Target Enrollment: 900 across all sites
Funder: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)
Duration of Study: 5.5 years

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UTHealth Houston Principal Investigator

Thao Nguyen, DO, FAAP

Links & Resources

ClinicalTrials.gov

 

 

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