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NCT05311046

Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool

Sponsor: Computer Technology Associates, Inc.

View on ClinicalTrials.gov

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.

Official title: Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool Towards Early Recognition and Personalized Therapeutics

Key Details

Gender

All

Age Range

3 Months - 45 Years

Study Type

OBSERVATIONAL

Enrollment

12961

Start Date

2026-04-01

Completion Date

2029-03-31

Last Updated

2025-09-08

Healthy Volunteers

No

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.

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States