Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study
NEO-MENINGITIS
Zekai Tahir Burak Women's Health Research and Education Hospital
1 other identifier
observational
500
1 country
5
Brief Summary
Meningitis, defined as inflammation of the meninges caused by different pathogens, is a serious infection associated with high morbidity and mortality. It occurs more commonly in the neonatal period than in any other age group. Neonatal meningitis is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality. In this study, we aimed to evaluate epidemiology, treatment and prognosis of neonatal meningitis in a large-scale retrospective multicenter cohort study. The main objectives of this study were to assess the incidence, temporal trend, risk factors, causative organisms, and short term outcomes of neonatal meningitis in a large national cohort of newborn infants admitted to Turkey NICUs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJuly 9, 2019
July 1, 2019
4 months
July 2, 2019
July 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of neonatal meningitis
Occurrence of a meningitis in NICU within a specified period of time. (Number of neonatal meningitis cases / Total number of inpatients in the study period)
average of 5 years
Secondary Outcomes (3)
Causative organisms
average of 5 years
Neurodevelopmental Outcome
18 to 24 months
Mortality
up to 28 days
Eligibility Criteria
In this study, 1. Lumbar puncture performed due to suspected meningitis and 2. CSF laboratory findings are consistent with meningitis and 3. Positivity in CSF culture and/or CSF PCR 4. Neonates hospitalized between 1 January 2014 and 31 May 2019 will be included in the study. * The list of all cases diagnosed as on Neonatal Meningitis with growth in CSF culture and / or causative agent by CSF PCR will be obtained from the hospital's database. * Term infants will be included in the study until 1 month and preterm infants will be adjusted until the first month.
You may qualify if:
- Subject has a positive cerebrospinal fluid culture/PCR of bacterial pathogen.
- Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥20 /mm3.
You may not qualify if:
- Major congenital anomalies
- Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Zekai Tahir Burak Women's Health Research and Education Hospital
Ankara, Turkey (Türkiye)
Bursa Yuksek Ihtisas Research and Education Hospital
Bursa, Turkey (Türkiye)
Gazi Yasargil Education Research Hospital
Diyarbakır, Turkey (Türkiye)
İstanbul Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
Izmir Katip Celebi University, Medical Faculty
Izmir, 35590, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehmet Yekta Oncel, M.D.
Tepecik Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neonatology
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 5, 2019
Study Start
June 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
July 9, 2019
Record last verified: 2019-07