Neonatal Bacterial Meningitis Cohort
A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis
1 other identifier
observational
10,000
1 country
2
Brief Summary
Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Longer than P75 for all trials
2 active sites
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
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 8, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 17, 2018
April 1, 2018
3.1 years
April 8, 2018
April 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
neonatal bacterial meningitis risk score
Our researchers grade the patients with the neonatal bacterial meningitis risk score to identify patients with bacterial meningitis, patients with risk score ≤ 3 points considered to be the low-risk group, and patients with risk score \> 3.1 points considered the high-risk group, and the risk score model has no maximum or minimum value.
1 day
Study Arms (2)
derivation cohort
The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score
validation cohort
The data of validation cohort are used to validate the neonatal bacterial meningitis risk score
Interventions
In the validation cohort,according to the neonatal bacterial meningitis risk score, we will suggest neonates who reach certain score to take a lumbar puncture, but we will not interfere with clinicians' decision
Eligibility Criteria
Eligible participants were full-term neonates, aged older than 3 days, who were suspected with BM and received LPs.
You may qualify if:
- Subject has a positive cerebrospinal fluid culture of bacterial pathogen(s)
- Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥ 20×106/L
- Subject has counts of white blood cells in cerebrospinal fluid ≥ 20×106/L and counts of neutrophils ≥ 10×106/L as well as suspected clinical symptoms
You may not qualify if:
- History of brain trauma, brain tumor, cerebral palsy, epilepsy, and ventricular shunt device
- History of accepting neurosurgery
- Subject has missing data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Biospecimen
cerebrospinal fluid, blood, urine, excrement
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2018
First Posted
April 17, 2018
Study Start
December 1, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2023
Last Updated
April 17, 2018
Record last verified: 2018-04