Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Reduction of > 20 points of the Intellectual Quotient
研究概览
简要总结
The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, Listeria monocytogenes.
详细描述
Perinatal listeriosis is defined by the occurrence of maternal listeriosis at birth and/or of early-onset listeriosis in the neonate (defined by the positive culture of any sample of maternal or neonatal origin).
Neurological involvement is defined by the presence of inflammation of the cerebrospinal fluid of positive culture or the cerebro-spinal fluid.
Evaluation is performed at the age of 5 years, and includes WPPSI evaluation of the Intelligence Quotient (IQ), NEPSY evaluation of the executive functions and clinical evaluation checking for any motor, sensorial or other focal deficiency among 90 cases and 270 controls matched for gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from the MONALISA cohort (culture proven-maternal listeriosis)
- •Or Children from the EPIPAGE cohort (control group)
- •Written consent from the parent(s) or legal representative
排除标准
- •Children whose parents or legal representative would deny their consent
结局指标
主要结局
Reduction of > 20 points of the Intellectual Quotient
时间窗: Day 1
Evaluated by standard tests (WPPSI-IV)
次要结局
- Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)(Day 1)
- Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)(Day 1)
- Scores obtained at NEPSY-2 evaluation tests(Day 1)
- Score obtained at M-ABC evaluation test (Movement-ABC)(Day 1)
- Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)(Day 1)
- Score obtained at SCQ evaluation test (Social Communication Questionnaire)(Day 1)
- Score obtained at Vineland Scale(Day 1)