A STUDY ON CEREBROSPINAL FLUID INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL MENINGITIS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- cerebrospinal fluid analysis in neonates
研究概览
简要总结
CSF culture is considered the gold standard for diagnosing bacterial meningitis. However, CSF culture typically takes atleast two days or more to be positive. and limited positivity rate (7.6percent). It is estimated that 30 to 50percent of neonatal samples are contaminated with blood, Increasing the white blood cell count and proteins. Interleukin 6, is transiently produced in response to infections and tissue injuries. Numerous studies have supported the role of interleukin 6 as a early biomarker of meningitis in adult and paediatric population, whereas limited number of studies noted in neonates. Thus ,this study tries to assess the role of interleukin 6 as the early biomarker in diagnosis of neonatal meningitis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates less than 28 days of age
- •Clinical suspicion of sepsis
- •Indication for lumbar puncture as per unit protocol.
排除标准
- •Neonates who had received antibiotics for ≥ 3 days
- •Recent brain surgery/ventricular tap
- •Moribound condition in which life expectancy less than 24hours
- •Grossly traumatic taps
- •Major congenital malformations – meningomyelocele /vertebral anamolies.
- •Presence of deep seated focus of infection other than meningitis e.g. abscess, septic arthritis etc.
- •Hemodynamic instability, bleeding disorder and coagulopathy.
- •Presence of infection at the lumbar puncture site.
结局指标
主要结局
cerebrospinal fluid analysis in neonates
时间窗: At baseline
TERM newborn : WBC more than 8 cells And Glucose less than 20 mg/dl OR Protein more than 120mg/dl
时间窗: At baseline
PRETERM: WBC more than 10 cells And Glucose less than 24mg/dl OR Protein more than 170mg/dl
时间窗: At baseline
With or without CSF culture positivity.
时间窗: At baseline
次要结局
未报告次要终点
研究者
Dr NIVEDEETHA K
INDIRA GANDHI INSTITUTE OF CHILD HEALTH