Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Computer Technology Associates, Inc.
Study ID
NCT05311046
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
3 Months - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Pediatric sepsis screening tool (either algorithmic or manual) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Sep 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
12,961 participants (estimated)

Arms

  • Arm: Retrospective EHR-data only group
    Members of this group are pediatric patients between the ages of 3 months to 45 years inclusive, that presented to one of the six participating institution's emergency department between the years 2016-2021 and screened positive for suspicion of sepsis using the institution's existing pediatric sepsis screening protocol and receive a blood culture order. Current pediatric screening/alerting tools are known to be highly sensitive but poorly specific. "Cases" in this cohort will be comprised of those that are ultimately diagnosed with sepsis and/or receive protocolized sepsis treatment. "Controls" in this cohort will be those with a false positive alert, i.e., are not diagnosed with sepsis and do not receive protocolized sepsis treatment.
  • Arm: Prospective EHR and Biomarker data group
    Members of this group are pediatric patients between the ages of 3 months to 45 years inclusive, that presented to one of the six participating institution's emergency department during the study enrollment period, screen positive for suspicion of sepsis using the institution's existing pediatric sepsis screening protocol, receive a blood culture order and provide informed consent/assent for the collection of a 1-5 mL blood sample to be used to measure PERSEVERE biomarkers. Members of this cohort will have also consented to the reuse of their medical record data for the research. Current pediatric screening/alerting tools are known to be highly sensitive but poorly specific. "Cases" in this cohort will be comprised of those that are ultimately diagnosed with sepsis and/or receive protocolized sepsis treatment. "Controls" in this cohort will be those with a false positive alert, i.e., are not diagnosed with sepsis and do not receive protocolized sepsis treatment.

Primary Outcome Measure

Effective Expert System-based Pediatric Sepsis Screening Tool (PSCT) [ Time Frame: Final 3 months of study period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Ioannis Koutroulis

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By research site
Children's National Hospital· Washington D.C., DC

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