# Collaborative Pediatric Critical Care Research Network

> **NIH NIH PL1** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2021 · $2,413,174

## Abstract

Project Summary
 In 2005, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
established the Collaborative Pediatric Critical Care Research Network (CPCCRN) to support multi-institutional
randomized controlled trials (RCTs) and observational studies in critically ill children. This PL1 proposal from the
University of Utah is submitted on behalf of a newly conﬁgured CPCCRN network increased to 12 Clinical Sites
and 12 ancillary sites with > 61,000 annual ICU admissions. The expanded network has geographic, racial/ethnic
and socioeconomic diversity, and will be a platform to develop additional investigators, especially young clinician
scientists. The network will conduct a highly innovative large-scale multi-center study of personalized, targeted
immune modulation in children with sepsis-induced multiple organ dysfunction syndrome (MODS). The study
includes two concurrent, immunophenotype-driven placebo controlled RCTs that will address the central hypoth-
esis that individualized, pathophysiology-speciﬁc immunomodulation will improve outcomes from sepsis-induced
MODS in children. This study builds on R01-funded CPCCRN studies that have demonstrated the existence of
speciﬁc immune phenotypes among children with sepsis-induced MODS (R01GM108618 PI: Carcillo) and suc-
cessful reversal of immunosuppression by administration of the immunostimulant granulocyte macrophage-colony
stimulating factor (GM-CSF) (R01GM094203 PI: Hall). It also complements the ongoing NICHD R01-funded study
investigating the risk factors for immunoparalysis in pediatric MODS (R01HD095976 MPI: Hall, Zuppa).
 This application has three speciﬁc aims: (1) Implement the CPCCRN organization; (2) Mount a comprehen-
sive strategy for development of young clinician scientists and submission of rigorous proposals to fund additional
research in critical care; (3) Conduct the Personalized Immunomodulation in Sepsis-induced MODS study. The
ﬁrst trial focuses on the use of the drug GM-CSF for the reversal of immunoparalysis. The second trial uses
adaptive randomization and focuses on the drugs anakinra and tocilizumab for the targeted treatment of hyper-
inﬂammation. The primary outcome of both trials will be duration and severity of organ dysfunction using the
cumulative PELOD-2 score, and secondary outcomes will assess health related quality of life and family function-
ing at 3 and 12 months.
 The Personalized Immunomodulation in Sepsis-Induced MODS study represents a paradigm shift in the man-
agement of pediatric sepsis, ﬁnally moving beyond simple supportive care. We are uniquely positioned to suc-
cessfully execute this approach to personalized, real-time, pathophysiology-directed sepsis treatment, leveraging
the strengths of a diverse and highly accomplished group of investigators to deliver high-impact science to the
beneﬁt of our patients and our ﬁeld.

## Key facts

- **NIH application ID:** 10248812
- **Project number:** 1PL1HD105462-01
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Jonathan Michael Dean
- **Activity code:** PL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,413,174
- **Award type:** 1
- **Project period:** 2021-08-13 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10248812

## Citation

> US National Institutes of Health, RePORTER application 10248812, Collaborative Pediatric Critical Care Research Network (1PL1HD105462-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10248812. Licensed CC0.

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