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Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study

Zekai Tahir Burak Women's Health Research and Education Hospital

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04009551
Acronym
NEO-MENINGITIS
Enrollment
500
Registered
2019-07-05
Start date
2019-06-01
Completion date
2019-10-01
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Meningitis

Keywords

meningitis, epidemiology, neonate, newborn

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.

Interventions

None listed

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of neonatal meningitisaverage of 5 yearsOccurrence of a meningitis in NICU within a specified period of time. (Number of neonatal meningitis cases / Total number of inpatients in the study period)

Secondary

MeasureTime frameDescription
Causative organismsaverage of 5 yearsNumber and types of isolated microorganisms in CSF cultures
Neurodevelopmental Outcome18 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.
Mortalityup to 28 daysNeonatal meningitis related mortality

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet Yekta Oncel, M.D.
dryekta@gmail.com+902323394581
Backup ContactEda Karadag Oncel, M.D.
dredakaradag@gmail.com+902324696969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026