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Neonatal Bacterial Meningitis Cohort

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Bacterial Meningitis
Neonatal Infection

Treatments

Diagnostic Test: neonatal bacterial meningitis risk score

Study type

Observational

Funder types

Other

Identifiers

NCT03499652
XH-17-017

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

1 to 28 days old

Volunteers

Accepts Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

derivation cohort
Description:
The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score
Treatment:
Diagnostic Test: neonatal bacterial meningitis risk score
validation cohort
Description:
The data of validation cohort are used to validate the neonatal bacterial meningitis risk score
Treatment:
Diagnostic Test: neonatal bacterial meningitis risk score

Trial contacts and locations

2

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Central trial contact

Yongjun Zhang, doctor

Data sourced from clinicaltrials.gov

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