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Life sciences · Observational Study
ClinicalTrials.gov · October 27, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT05311046). This is a study registration, not published results. Lead sponsor: Computer Technology Associates, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 12961 participants (ESTIMATED). Conditions: Sepsis. Interventions: DIAGNOSTIC_TEST: Pediatric sepsis screening tool (either algorithmic or manual). Primary outcome measures: Effective Expert System-based Pediatric Sepsis Screening Tool (PSCT) , Final 3 months of study period.; High performance Expert System-based Pediatric Sepsis Screening Tool (PSCT) , Using "early data" following presentation to ED, e.g., upon receipt of biomarker data within 1st 3 hours of presentation). Brief 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.