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

NCT ID: NCT04009551

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Meningitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Yekta Oncel

Head of Neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Yekta Oncel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tepecik Training and Research Hospital

Locations

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Zekai Tahir Burak Women's Health Research and Education Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Gazi Yasargil Education Research Hospital

Diyarbakır, , Turkey (Türkiye)

Site Status RECRUITING

İstanbul Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Izmir Katip Celebi University, Medical Faculty

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Yekta Oncel, M.D.

Role: CONTACT

+902323394581

Eda Karadag Oncel, M.D.

Role: CONTACT

+902324696969

Facility Contacts

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Fuat Emre Canpolat, M.D.

Role: primary

+903123065000

Mehmet Nevzat Cizmeci, M.D.

Role: primary

+902242955000

Nilufer Okur, M.D.

Role: primary

+904122519129

Merih Cetinkaya, M.D.

Role: primary

+902124041500

Mehmet Yekta Oncel, MD

Role: primary

+902323394581

Other Identifiers

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Tepecik35

Identifier Type: -

Identifier Source: org_study_id

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