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A Controlled Mouse Model for Neonatal Polymicrobial Sepsis
Published on: January 27, 2019
Protocol for a multi-country retrospective observational paediatric sepsis epidemiological study (SENTINEL
Elliot Long1,2,3,4, Amanda Williams2, Shane George5,6,7
1Emergency, The Royal Children's Hospital Melbourne, Melbourne, Victoria, Australia Elliot.long@rch.org.au.
Insights
This study analyzes childhood sepsis in low- and middle-income countries to understand disease burden and improve outcomes. Data collection will inform future international trials for better childhood sepsis care.
Area of Science:
- Pediatric Infectious Diseases
- Global Health
- Epidemiology
Background:
- Childhood sepsis remains a global health priority with high mortality, especially in low- and middle-income countries (LMICs).
- Understanding the burden of disease, including incidence, severity, and outcomes, is crucial for improving care.
- Existing data on childhood sepsis in LMICs is limited, hindering effective intervention development.
Purpose of the Study:
- To establish a comprehensive database of children with community-acquired childhood sepsis in LMICs and high-income countries.
- To analyze the incidence, severity, and outcomes of childhood sepsis.
- To provide fundamental insights for designing future international interventional trials to improve childhood sepsis outcomes.
Main Methods:
- A multicountry retrospective observational study including children up to 18 years presenting with suspected sepsis.
- Sepsis definition includes hospital admission for intravenous antibiotics plus a provisional sepsis diagnosis or treatment for suspected sepsis (fluid bolus/vasoactive infusion).
- Data collected includes presenting characteristics, management (fluids, organ support, antimicrobials), microbiological diagnoses, and outcomes (LOS, mortality).
Main Results:
- Data collection is ongoing for this multicountry retrospective observational study.
- The study aims to provide a detailed analysis of childhood sepsis presentation, management, and outcomes.
- Results will elucidate the burden of childhood sepsis in diverse settings.
Conclusions:
- This study will generate critical data on childhood sepsis in LMICs and high-income countries.
- Findings will inform the development of targeted interventions and clinical trial designs.
- Improving the understanding of childhood sepsis is essential for reducing mortality and morbidity globally.
Introduction:
Improving outcomes from sepsis in children is a WHO Global Health Priority, yet mortality from sepsis remains high, particularly in low- and middle-income countries (LMICs). This database from children with community-acquired childhood sepsis in LMICs and some high-income countries will allow analysis of the burden of disease, including incidence, severity and outcomes. Understanding these aspects of sepsis care is fundamental for the design and conduct of future international interventional trials to improve childhood sepsis outcomes.
Methods And Analysis:
This multicountry retrospective observational study will include children up to 18 years of age presenting to emergency departments with suspected sepsis, defined as admission to hospital for treatment with intravenous antibiotics plus (1) a provisional diagnosis of sepsis and/or (2) treatment for suspected sepsis (operationalised as the administration of one or more fluid bolus to treat impaired perfusion or vasoactive infusion). Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length of stay, and mortality censored at hospital discharge or 30 days from enrolment (whichever occurs first).
Ethics And Dissemination:
Central ethics approval was received from the Royal Children's Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/100648/RCHM-2023). Each international site will be required to obtain local Institutional Research Ethics Board approval. The findings will be disseminated in peer-reviewed journals, at academic conferences and through lay media. A cleaned study database and individual site-level data will be made available to site investigators upon completion of the study.
Trial Registration Number:
This study was registered with the Australian and New Zealand Clinical Trials Registry on 23 January 2024 prior to commencement of recruitment (ACTRN12624000052538).
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