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.
Condition or disease |
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Neonatal Meningitis |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Zekai Tahir Burak Women's Health Research and Education Hospital |
Actual Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | October 1, 2019 |
Estimated Study Completion Date : | October 1, 2019 |
Ages Eligible for Study: | up to 30 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
In this study,
Neonates hospitalized between 1 January 2014 and 31 May 2019 will be included in the study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Mehmet Yekta Oncel, M.D. | +902323394581 | dryekta@gmail.com | |
Contact: Eda Karadag Oncel, M.D. | +902324696969 | dredakaradag@gmail.com |
Turkey | |
Zekai Tahir Burak Women's Health Research and Education Hospital | Recruiting |
Ankara, Turkey | |
Contact: Fuat Emre Canpolat, M.D. +903123065000 femrecan@gmail.com | |
Bursa Yuksek Ihtisas Research and Education Hospital | Recruiting |
Bursa, Turkey | |
Contact: Mehmet Nevzat Cizmeci, M.D. +902242955000 nevzatcizmeci@gmail.com | |
Gazi Yasargil Education Research Hospital | Recruiting |
Diyarbakır, Turkey | |
Contact: Nilufer Okur, M.D. +904122519129 n.matur@hotmail.com | |
İstanbul Kanuni Sultan Süleyman Training and Research Hospital | Recruiting |
İstanbul, Turkey | |
Contact: Merih Cetinkaya, M.D. +902124041500 drmerih@yahoo.com | |
Izmir Katip Celebi University, Medical Faculty | Recruiting |
İzmir, Turkey, 35590 | |
Contact: Mehmet Yekta Oncel, MD +902323394581 dryekta@gmail.com |
Principal Investigator: | Mehmet Yekta Oncel, M.D. | Tepecik Training and Research Hospital |
Tracking Information | |||||||||
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First Submitted Date | July 2, 2019 | ||||||||
First Posted Date | July 5, 2019 | ||||||||
Last Update Posted Date | July 9, 2019 | ||||||||
Actual Study Start Date | June 1, 2019 | ||||||||
Estimated Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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)
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study | ||||||||
Official Title | Zekai Tahir Burak Women's Health Research and Education Hospital | ||||||||
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. |
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Detailed Description | Not Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population |
In this study,
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Condition | Neonatal Meningitis | ||||||||
Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
500 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | October 1, 2019 | ||||||||
Estimated Primary Completion Date | October 1, 2019 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 30 Days (Child) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Turkey | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04009551 | ||||||||
Other Study ID Numbers | Tepecik35 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Mehmet Yekta Oncel, Tepecik Training and Research Hospital | ||||||||
Study Sponsor | Zekai Tahir Burak Women's Health Research and Education Hospital | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Zekai Tahir Burak Women's Health Research and Education Hospital | ||||||||
Verification Date | July 2019 |