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Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool

NCT05311046 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 12961

Last updated 2025-09-08

No results posted yet for this study

Summary

The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's electronic health record (EHR) system to monitor and assess real-time emergency department (ED) electronic health record (EHR) data towards the enhancement of early pediatric sepsis recognition and the initiation of timely, aggressive personalized sepsis therapy known to improve patient outcomes.

It is hypothesized that the screening performance (e.g., positive predictive value) of the envisioned screening tool will be significantly enhanced by the inclusion of a biomarker panel test results (PERSEVERE) that have been shown to be effective in prediction of clinical deterioration in non-critically ill immunocompromised pediatric patients evaluated for infection. It is also hypothesized that enhanced phenotypes can be derived by clustering PERSEVERE biomarkers combined with routinely collected EHR data towards improved personalized medicine.

Conditions

Interventions

DIAGNOSTIC_TEST

Pediatric sepsis screening tool (either algorithmic or manual)

All participating institutions employ either an algorithmic, manual, or combined algorithmic/manual pediatric sepsis screening protocol for patients that present with fever and/or a concern for infection. While the specific parameters tested in screening tools differ, they generally consist of tests for a systemic inflammatory response (e.g. SIRS) and/or organ dysfunction (e.g. SOFA) and/or high susceptibility (e.g. immunocompromised) factors.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Rainbow Babies and Children's Hospital

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • George Washington University

    collaborator OTHER

  • All Children's Research Institute

    collaborator UNKNOWN

  • Computer Technology Associates, Inc.

    lead INDUSTRY

Principal Investigators

  • Carmelo "Tom" E Velez, PhD · CTA

Eligibility

Min Age
3 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05311046 on ClinicalTrials.gov