Neonatal Bacterial Meningitis Cohort

A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Meningitis; Neonatal Infection
• Intervention / Treatment: Diagnostic test: neonatal bacterial meningitis risk score

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Yongjun Zhang, doctor; Phone Number: +8602125078310; Email: zhangyongjun@stju.edu.cn

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Yongjun Zhang, doctor
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Yongjun Zhang, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible participants were full-term neonates, aged older than 3 days, who were suspected with BM and received LPs.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Children's Hospital of Fudan University; Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 8, 2018
• First Submitted That Met QC Criteria: April 15, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 15, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Meningitis; Meningitis, Bacterial
• Other Study ID Numbers: XH-17-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: we plan to share all the individual participant data information available to our cooperative hospitals through emails

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No