Status:
NOT_YET_RECRUITING
Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
Lead Sponsor:
Computer Technology Associates, Inc.
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Rainbow Babies and Children's Hospital
Conditions:
Sepsis
Eligibility:
All Genders
3-45 years
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 combi...
Detailed Description
Background and Rationale Existing automated pediatric sepsis screening tools (PSCT) based on consensus criteria currently used in emergency departments do not improve early recognition and/or inform p...
Eligibility Criteria
Inclusion
- Patients 3 months -45 years of age, inclusive
- Diagnosed with sepsis by a clinician or trigger a sepsis alert and a blood culture is ordered. Controls will be false positive patients.
- For those patients that will be prospectively enrolled for blood sample collection: will require a venipuncture or intravenous line placement.
Exclusion
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients with parents or LARs that don't speak English or Spanish
- Pregnancy
Key Trial Info
Start Date :
April 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
12961 Patients enrolled
Trial Details
Trial ID
NCT05311046
Start Date
April 1 2026
End Date
March 31 2029
Last Update
September 8 2025
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010