Neonatal Bacterial Meningitis Cohort

NCT03499652 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2018-04-17

No results posted yet for this study

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.

Conditions

  • Bacterial Meningitis
  • Neonatal Infection

Interventions

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

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    collaborator OTHER
  • Children's Hospital of Fudan University

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499652 on ClinicalTrials.gov