Status:
UNKNOWN
nSeP: Detecting Neonatal Sepsis by Immune-Metabolic Network Analysis
Lead Sponsor:
Cardiff and Vale University Health Board
Collaborating Sponsors:
Cardiff University
Conditions:
Sepsis
Eligibility:
All Genders
Up to 4 years
Brief Summary
Diagnosis of neonatal sepsis remains a challenge due to non-specific signs and diagnostic inaccuracies. Studies have shown that this could lead to overdiagnosis and overuse of antibiotic treatment, wi...
Detailed Description
Several studies have shown that changes in host gene expression may occur pre- symptomatically in response to infection in any part of the body, with the continuous interaction between blood and tissu...
Eligibility Criteria
Inclusion
- Screened with traditional tests (full-blood count \[FBC\], inflammatory markers like C-reactive protein \[CRP\], and blood-culture) for suspected sepsis (including non-infective inflammatory conditions) and started on antibiotics - potential cases.
- Being sampled for non-septic conditions (bloods sampling for routine monitoring, jaundice, hypoglycaemia, etc.) - controls.
- Informed consent from parents to use blood and stool samples (initial sample and 24-hour sample) and clinical data for study.
Exclusion
- Language and communication issues, which will make it difficult to explain study and request informed consent.
- When an infant has a high chance of mortality in the next 24-hours.
Key Trial Info
Start Date :
February 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03777670
Start Date
February 26 2020
End Date
February 28 2024
Last Update
April 7 2020
Active Locations (1)
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1
University Hospital of Wales
Cardiff, South Glamorgan, United Kingdom, CF14 4XN