nSeP: Detecting Neonatal Sepsis by Immune-Metabolic Network Analysis
nSeP
Detecting Neonatal Sepsis by Immune-Metabolic Network Analysis
1 other identifier
observational
1,000
1 country
1
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, with potential long-term adverse effects. A systems approach towards diagnosing neonatal sepsis has been shown to have high accuracy in initial studies. This study aims to recruit a large validation cohort to confirm findings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedStudy Start
First participant enrolled
February 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedApril 7, 2020
April 1, 2020
3 years
December 13, 2018
April 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sepsis
Immune signature of sepsis
5-years
Study Arms (2)
Cases
Infants with suspected sepsis
Controls
Infants with no suspicion of sepsis
Interventions
Eligibility Criteria
Newborn infants in the neonatal unit with a suspicion of sepsis
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiff and Vale University Health Boardlead
- Cardiff Universitycollaborator
Study Sites (1)
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XN, United Kingdom
Related Publications (1)
Chakraborty M, Rodrigues PRS, Watkins WJ, Hayward A, Sharma A, Hayward R, Smit E, Jones R, Goel N, Asokkumar A, Calvert J, Odd D, Morris I, Doherty C, Elliott S, Strang A, Andrews R, Zaher S, Sharma S, Bell S, Oruganti S, Smith C, Orme J, Edkins S, Craigon M, White D, Dantoft W, Davies LC, Moet L, McLaren JE, Clarkstone S, Watson GL, Hood K, Kotecha S, Morgan BP, O'Donnell VB, Ghazal P. nSeP: immune and metabolic biomarkers for early detection of neonatal sepsis-protocol for a prospective multicohort study. BMJ Open. 2021 Dec 30;11(12):e050100. doi: 10.1136/bmjopen-2021-050100.
PMID: 37010923DERIVED
Biospecimen
RNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant in Neonatal Medicine
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 17, 2018
Study Start
February 26, 2020
Primary Completion
February 28, 2023
Study Completion
February 28, 2024
Last Updated
April 7, 2020
Record last verified: 2020-04