NCT04685850终止不适用
Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 9
- 主要终点
- Number of children with at least one neurological, orthopedic or sensory sequelae
研究概览
简要总结
While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.
The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children from 0 to 17 years old
- •Having had meningitis or meningococcal purpura fulminans between 2010 and 2021
- •Delay ≥ 1 year between the date of diagnosis of meningitis or purpura meningococcal fulminans and the date of inclusion in the study (signature of the informed consent)
- •The holders of parental authority have read and understood the information letter and their express consent has been obtained
- •Patient affiliated to a social security system (Social Security or Universal Medical Coverage)
排除标准
- •refusal to participate
结局指标
主要结局
Number of children with at least one neurological, orthopedic or sensory sequelae
时间窗: 1 year
次要结局
- Number of children with skin sequelae(1 year)
- Number of children with learning disabilities(1 year)
- Number of children with sensory disorders(1 year)
- Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity(1 year)
- Number of children with severe neurological sequelae(1 year)
- Number of children with orthopedic complications(1 year)
- Post-traumatic stress in parents using the IES-R questionnaire(1 year)
- Number of consultations during follow-up(1 year)
研究者
研究点 (9)
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