Bacterial Meningitis, Neonatal Infection
Conditions
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.
Interventions
DIAGNOSTIC_TESTneonatal 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
Shanghai Children's Medical Center
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYongjun Zhang, doctor
Outcome results
None listed