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Neonatal Bacterial Meningitis Cohort

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ClinicalTrials.gov Identifier: NCT03499652
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
Shanghai Children's Medical Center
Children's Hospital of Fudan University
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment
Bacterial Meningitis Neonatal Infection 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

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




Primary Outcome Measures :
  1. neonatal bacterial meningitis risk score [ Time Frame: 1 day ]
    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.


Biospecimen Retention:   Samples With DNA
cerebrospinal fluid, blood, urine, excrement


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499652


Contacts
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Contact: Yongjun Zhang, doctor +8602125078310 zhangyongjun@stju.edu.cn

Locations
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China, Shanghai
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yongjun Zhang, doctor         
China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
Contact: Yongjun Zhang, doctor         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Children's Medical Center
Children's Hospital of Fudan University

Additional Information:

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03499652     History of Changes
Other Study ID Numbers: XH-17-017
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: we plan to share all the individual participant data information available to our cooperative hospitals through emails

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Meningitis
Meningitis, Bacterial
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Central Nervous System Infections