# Collaborative Pediatric Critical Care Research Network - Clinical Site

> **NIH NIH RL1** · RESEARCH INST NATIONWIDE CHILDREN'S HOSP · 2024 · $152,460

## Abstract

PROJECT SUMMARY/ABSTRACT – Nationwide Children’s Hospital
Nationwide Children’s Hospital (54 pediatric ICU beds and 20 cardiothoracic ICU beds with a combined annual 
census of >3,500 patients) and our Ancillary Site, Rainbow Babies and Children’s Hospital (24 pediatric ICU 
beds with an annual census of >1,600 patients), will be strong assets to the 4th cycle of the Collaborative 
Pediatric Critical Care Research Network (CPCCRN). The overall aim of this proposal is to advance the field 
of pediatric critical care medicine through the collaborative development and execution of transformative 
studies that benefit critically ill children. As one of the current CPCCRN sites, we (Hall – PI, Yates – Co-I, 
Steel – RC) have consistently been leaders in subject enrollment and project development. Dr. Hall’s Immune 
Surveillance Laboratory (ISL) at the Abigail Wexner Research Institute at Nationwide Children’s Hospital has 
served a central role in the two interventional drug trials performed by the network this cycle. These trials 
using the immunostimulant drug GM-CSF for the reversal of critical illness-induced immune suppression, 
established the safety and feasibility of multi-center, real-time immune function monitoring and modulation in 
our hands and, along with the current cycle’s PHENOMS sepsis phenotyping study, led us directly to the 
proposed study, “Personalized Immunomodulation in Sepsis-induced MODS”. This study includes two distinct, 
embedded, double-blind, placebo-controlled, randomized clinical trials of immunomodulation that are tailored to 
each subject’s prospectively-tested immune phenotype. The ISL will provide highly standardized immune 
function and inflammation testing kits with which the network already has extensive experience. Subjects who 
are found to have severe immune suppression without severe inflammation will be allocated to the “GM-CSF 
for Reversal of Immunoparalysis in Sepsis-induced MODS (GRACE)-2” study where they will receive GM-CSF 
or placebo. Subjects with moderate to severe systemic inflammation will be allocated to the “Targeted 
Reversal of Inflammation in Pediatric Sepsis-induced MODS (TRIPS)” study in which subjects will be 
adaptively randomized to receive the anti-inflammatory drugs anakinra, tocilizumab, or placebo. This highly 
innovative approach is designed to ensure that the right subject receives the right immune care that matches 
their immunologic derangement. Our primary outcome, the cumulative PELOD-2 score over 28 days, will 
assess both ICU morbidity and mortality, and our secondary outcomes will assess long term morbidity and 
health-related quality of life. This project is an ideal platform for ancillary studies and will represent a 
transformative approach to sepsis care in children. Nationwide Children’s Hospital and Rainbow Babies and 
Children’s Hospital (Shein – PI, Slain – Co-I) are certain to be strong contributors and collaborators in the next 
cycle of CPCCRN and will help mov...

## Key facts

- **NIH application ID:** 10907711
- **Project number:** 5RL1HD107783-04
- **Recipient organization:** RESEARCH INST NATIONWIDE CHILDREN'S HOSP
- **Principal Investigator:** MARK W HALL
- **Activity code:** RL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $152,460
- **Award type:** 5
- **Project period:** 2021-08-18 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10907711

## Citation

> US National Institutes of Health, RePORTER application 10907711, Collaborative Pediatric Critical Care Research Network - Clinical Site (5RL1HD107783-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10907711. Licensed CC0.

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