Neonatal Bacterial Meningitis Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis

Conditions
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Bacterial Meningitis, Neonatal Infection

Intervention / Treatment
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* Diagnostic Test: neonatal bacterial meningitis risk score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of brain trauma, brain tumor, cerebral palsy, epilepsy, and ventricular shunt device History of accepting neurosurgery Subject has missing data

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| derivation cohort<br>The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score | Diagnostic Test: neonatal bacterial meningitis risk score<br>* 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<br>|
| validation cohort<br>The data of validation cohort are used to validate the neonatal bacterial meningitis risk score | Diagnostic Test: neonatal bacterial meningitis risk score<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |