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Paediatric Rapid Sepsis Trigger (PRST) Tool

NCT04304235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18693

Last updated 2025-05-13

Study results available
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Summary

Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent these challenges, we propose the development and clinical evaluation of a trigger tool that will reduce the time to diagnosis and prompt the timely initiation of life-saving treatment. The key innovations are 1) a data-driven approach to rapid diagnosis of sepsis severity and 2) a low- cost digital tagging system to track the time to treatment. The tool will require minimal cost, clinical expertise and training or time to use.

The tool will identify high risk children and reduce time to treatment. The digital platform (mobile device and dashboard) will create a low-cost, highly scalable solution for children with sepsis.

Conditions

Interventions

DEVICE

Pediatric Rapid Sepsis Trigger (PRST) tool

The digital platform consists of a mobile application integrating a pulse oximetry sensor attached to this device, with embedded smart algorithms that predict a critically ill state, or level of risk (below) in a child presenting at the hospital. The platform also includes an interactive dashboard located in strategic locations (e.g., laboratory, consultation rooms), which connects to the mobile application through a secure local network and displays the triage data to provide real-time monitoring for the physicians who manage the patients.

OTHER

Emergency Triage and Treatment (ETAT) guidelines

These are the triage guidelines currently applied in the study hospital sites. This will be the comparator group.

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • John M Ansermino · The University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • Kenya
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT04304235 on ClinicalTrials.gov