Neonatal Bacterial Meningitis Cohort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| derivation cohort The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score |
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
|
| validation cohort The data of validation cohort are used to validate the neonatal bacterial meningitis risk score |
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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200092 |
| 2 | Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China | 200092 |
Sponsors and Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Shanghai Children's Medical Center
- Children's Hospital of Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XH-17-017