Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assesment of persistent sequelae
研究概览
简要总结
Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.
The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.
The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.
The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children consulting for peripheral facial palsy
排除标准
- •Children consulting for central facial palsy
- •Children with congenital peripheral facial palsy
- •Children with surgery and trauma in the area of the facial nerve,
- •Children with peripheral facial palsy with previous diagnosis
- •Children whose parents refuse the study participation
研究组 & 干预措施
Telephonic interview
Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not
干预措施: telephonic interview (Other)
结局指标
主要结局
Assesment of persistent sequelae
时间窗: 4 years
Facial paralysis duration assesment and persistence of physical sequelae at time of the telephonic call using House \& Brackmann classification for facial function. This grading system has 6 levels, used for middle- to long-term monitoring: I. Normal II. Mild dysfunction III. Moderate dysfunction IV. Moderately severe dysfunction
次要结局
未报告次要终点