Neonatal Bacterial Meningitis Cohort

• Conditions: Neonatal Infection; Bacterial Meningitis
• Interventions: Diagnostic Test: neonatal bacterial meningitis risk score

• Registration Number: NCT03499652
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-12-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-08
• Study First Submitted QC: 2018-04-15
• Last Update Submitted: 2018-04-15
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17
• Primary Completion: 2020-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
derivation cohort	neonatal bacterial meningitis risk score	The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score
validation cohort	neonatal bacterial meningitis risk score	The data of validation cohort are used to validate the neonatal bacterial meningitis risk score

Primary Outcome Measures

Name	Time	Method
neonatal bacterial meningitis risk score	1 day	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.

Trial Locations

Locations (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China