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.
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
-
Ankara、火鸡
- 招聘中
- Zekai Tahir Burak Women's Health Research and Education Hospital
-
接触：
- Fuat Emre Canpolat, M.D.
- 电话号码：+903123065000
- 邮箱：femrecan@gmail.com
-
Bursa、火鸡
- 招聘中
- Bursa Yuksek Ihtisas Research and Education Hospital
-
接触：
- Mehmet Nevzat Cizmeci, M.D.
- 电话号码：+902242955000
- 邮箱：nevzatcizmeci@gmail.com
-
Diyarbakır、火鸡
- 招聘中
- Gazi Yasargil Education Research Hospital
-
接触：
- Nilufer Okur, M.D.
- 电话号码：+904122519129
- 邮箱：n.matur@hotmail.com
-
İstanbul、火鸡
- 招聘中
- Istanbul Kanuni Sultan Suleyman Training and Research Hospital
-
接触：
- Merih Cetinkaya, M.D.
- 电话号码：+902124041500
- 邮箱：drmerih@yahoo.com
-
İzmir、火鸡、35590
- 招聘中
- Izmir Katip Celebi University, Medical Faculty
-
接触：
- Mehmet Yekta Oncel, MD
- 电话号码：+902323394581
- 邮箱：dryekta@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of neonatal meningitis
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Causative organisms
大体时间：average of 5 years
|
Number and types of isolated microorganisms in CSF cultures
|
average of 5 years
|
|
Neurodevelopmental Outcome
大体时间：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
大体时间：up to 28 days
|
Neonatal meningitis related mortality
|
up to 28 days
|
合作者和调查者
调查人员
- 首席研究员：Mehmet Yekta Oncel, M.D.、Tepecik Training and Research Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.