NCT03499652

Neonatal Bacterial Meningitis Cohort

A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

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.

Conditions

• Bacterial Meningitis
• Neonatal Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	neonatal bacterial meningitis risk score	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

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-12-31
• Completion: 2023-12-31
• First posted: 2018-04-17
• Last updated: 2018-04-17

Locations

2 sites across 1 country: China