Zekai Tahir Burak Women's Health Research and Education Hospital
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Incidence of neonatal meningitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Major congenital anomalies
- •Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
结局指标
主要结局
Incidence of neonatal meningitis
时间窗: 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)
次要结局
- Causative organisms(average of 5 years)
- Neurodevelopmental Outcome(18 to 24 months)
- Mortality(up to 28 days)
研究者
Mehmet Yekta Oncel
Head of Neonatology
Tepecik Training and Research Hospital