Neonatal Bacterial Meningitis Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Childern

NCT04929925

CNS Infection in Children

UNKNOWN

Paediatric Infections Point-Of-Care

NCT03900091

Meningitis Pediatric Infectious Diseases

COMPLETED

Febrile Infant Diagnostic Assessment and Outcome Study

NCT05259683

Urinary Tract Infections Meningitis Sepsis +1 more

COMPLETED

Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

NCT00326313

Infants With Positive GBS Bacteremia

UNKNOWN

Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months

NCT00800488

Fever Bacterial Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Meningitis Neonatal Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

derivation cohort

The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score

neonatal bacterial meningitis risk score

Intervention Type DIAGNOSTIC_TEST

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

neonatal bacterial meningitis risk score

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes