Neonatal Bacterial Meningitis Cohort

Neonatal Infection Clinical Trial

Official title:

A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03499652
• Other study ID #: XH-17-017
• Status: Recruiting
• First received: April 8, 2018
• Last updated: April 15, 2018
• Start date: December 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yongjun Zhang, doctor
• Phone: +8602125078310
• Email: zhangyongjun[@]stju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Meningitis
• Meningitis
• Meningitis, Bacterial
• Neonatal Infection

Intervention

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

Locations

Country	Name	City	State
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Children's Hospital of Fudan University, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day