- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Ankara, Kalkun
- Rekruttering
- Zekai Tahir Burak Women's Health Research and Education Hospital
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Kontakt:
- Fuat Emre Canpolat, M.D.
- Telefonnummer: +903123065000
- E-mail: femrecan@gmail.com
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Bursa, Kalkun
- Rekruttering
- Bursa Yuksek Ihtisas Research and Education Hospital
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Kontakt:
- Mehmet Nevzat Cizmeci, M.D.
- Telefonnummer: +902242955000
- E-mail: nevzatcizmeci@gmail.com
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Diyarbakır, Kalkun
- Rekruttering
- Gazi Yasargil Education Research Hospital
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Kontakt:
- Nilufer Okur, M.D.
- Telefonnummer: +904122519129
- E-mail: n.matur@hotmail.com
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İstanbul, Kalkun
- Rekruttering
- Istanbul Kanuni Sultan Suleyman Training and Research Hospital
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Kontakt:
- Merih Cetinkaya, M.D.
- Telefonnummer: +902124041500
- E-mail: drmerih@yahoo.com
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İzmir, Kalkun, 35590
- Rekruttering
- Izmir Katip Celebi University, Medical Faculty
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Kontakt:
- Mehmet Yekta Oncel, MD
- Telefonnummer: +902323394581
- E-mail: dryekta@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of neonatal meningitis
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Causative organisms
Tidsramme: average of 5 years
|
Number and types of isolated microorganisms in CSF cultures
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average of 5 years
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Neurodevelopmental Outcome
Tidsramme: 18 to 24 months
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- 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.
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18 to 24 months
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Mortality
Tidsramme: up to 28 days
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Neonatal meningitis related mortality
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up to 28 days
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Mehmet Yekta Oncel, M.D., Tepecik Training and Research Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tepecik35
Plan for individuelle deltagerdata (IPD)
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