- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009551
Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study (NEO-MENINGITIS)
Zekai Tahir Burak Women's Health Research and Education Hospital
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mehmet Yekta Oncel, M.D.
- Phone Number: +902323394581
- Email: dryekta@gmail.com
Study Contact Backup
- Name: Eda Karadag Oncel, M.D.
- Phone Number: +902324696969
- Email: dredakaradag@gmail.com
Study Locations
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-
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Ankara, Turkey
- Recruiting
- Zekai Tahir Burak Women's Health Research and Education Hospital
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Contact:
- Fuat Emre Canpolat, M.D.
- Phone Number: +903123065000
- Email: femrecan@gmail.com
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Bursa, Turkey
- Recruiting
- Bursa Yuksek Ihtisas Research and Education Hospital
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Contact:
- Mehmet Nevzat Cizmeci, M.D.
- Phone Number: +902242955000
- Email: nevzatcizmeci@gmail.com
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Diyarbakır, Turkey
- Recruiting
- Gazi Yasargil Education Research Hospital
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Contact:
- Nilufer Okur, M.D.
- Phone Number: +904122519129
- Email: n.matur@hotmail.com
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İstanbul, Turkey
- Recruiting
- Istanbul Kanuni Sultan Suleyman Training and Research Hospital
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Contact:
- Merih Cetinkaya, M.D.
- Phone Number: +902124041500
- Email: drmerih@yahoo.com
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İzmir, Turkey, 35590
- Recruiting
- Izmir Katip Celebi University, Medical Faculty
-
Contact:
- Mehmet Yekta Oncel, MD
- Phone Number: +902323394581
- Email: dryekta@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
In this study,
- Lumbar puncture performed due to suspected meningitis and
- CSF laboratory findings are consistent with meningitis and
- Positivity in CSF culture and/or CSF PCR
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Major congenital anomalies
- Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of neonatal meningitis
Time Frame: average of 5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Causative organisms
Time Frame: average of 5 years
|
Number and types of isolated microorganisms in CSF cultures
|
average of 5 years
|
Neurodevelopmental Outcome
Time Frame: 18 to 24 months
|
- Bayley Scales of Infant Development, Second Edition (BSID II), was performed a comprehensive assessment including neurological and developmental evaluation.
The mean BSID II score is 100 for Mental Developmental Index (MDI) and Psychomotor Developmental Index (PDI), with a standard deviation (SD) of 15; a score of less than 70 (42 SDs below the mean) indicates a significant delay.
Infants who were so severely impaired that testing with the BSID II could not be performed were assigned a MDI and PDI score of 49.
|
18 to 24 months
|
Mortality
Time Frame: up to 28 days
|
Neonatal meningitis related mortality
|
up to 28 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mehmet Yekta Oncel, M.D., Tepecik Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tepecik35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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