# 1/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

> **NIH NIH UH3** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $4,073,947

## Abstract

Project Summary
Out-of-hospital cardiac arrest (OHCA) in children is a tragic event that usually results in death or permanent
brain injury in survivors. More than 7000 children suffer OHCA each year in the US and improvements in
pediatric OHCA outcomes, just as in adults, is very much limited by our ability to protect the brain from global
cerebral ischemic injury in those who are successfully resuscitated. Targeted temperature management (TTM)
is currently guideline-recommended in children following OHCA with preference stated for therapeutic
hypothermia (TTM 32-34°C) over normothermia (TTM 36-37.5°C) in order to prevent fever which could amplify
brain injury. The optimal duration and patient selection criteria for therapeutic hypothermia in children remain
unknown and cooling devices are not specifically FDA approved for this indication. Preclinical data and
mechanistic studies strongly suggest that durations of hypothermia longer than those typically used in adults
may minimize brain injury. This study will determine if identifying an optimal duration (dose) of therapeutic
hypothermia can improve outcomes, and if development of a duration response curve can confirm efficacy in a
wider pediatric population of OHCA survivors. We hypothesize that longer durations of cooling will improve
survival and result in better neurologic recovery in survivors compared to shorter cooling durations, as
assessed by the Vineland Adaptive Behavior Scales–Third Edition (Vineland-3) score. The primary goal of this
project is to identify clinical strategies that will increase the number of patients with improved neurological
recovery from OHCA. The results of this trial will be extremely significant in children and will immediately
impact both clinical practice and regulatory evaluation. The Pediatric Influence of Cooling duration on Efficacy
in Cardiac Arrest Patients (P-ICECAP) trial, modeled after the ongoing adult ICECAP trial, uses innovative
adaptive dose finding methods that allow exploration of a wide range of potential durations and efficiently
allocate subjects where they will be most informative. The study will be conducted using resources of the
NHLBI/NINDS Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), which is experienced
in both pediatric and adult trials, and is currently conducting the current adult ICECAP Trial. SIREN leverages
existing resources to achieve economies of scale and to conduct important clinical investigations spanning
from pre-hospital, through both the emergency department and ICU stay, and post hospital discharge.

## Key facts

- **NIH application ID:** 10922751
- **Project number:** 5UH3HL159134-04
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** FRANK W MOLER
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $4,073,947
- **Award type:** 5
- **Project period:** 2021-09-15 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922751

## Citation

> US National Institutes of Health, RePORTER application 10922751, 1/2 Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) (5UH3HL159134-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10922751. Licensed CC0.

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