An observational study in Bacterial Meningitis and Neonatal Infection, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 2 sites in China. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational
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.
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.
Eligible participants were full-term neonates, aged older than 3 days, who were suspected with BM and received LPs.
Exclusion Criteria:
The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score
Diagnostic Test: neonatal bacterial meningitis risk score
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
neonatal bacterial meningitis risk score
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.
Time frame: 1 day
Plan to share: Undecided — we plan to share all the individual participant data information available to our cooperative hospitals through emails
No publications or documents are linked to this record.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine