Long-term Follow-up of Safety and Efficacy of OnabotulinumtoxinA for Treatment of Sialorrhea in Juvenile Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS)
研究概览
简要总结
A 100 units of botulinum toxin was injected in both parotid and submandibular glands for children (2 - 12 years) with incapacitating sialorrhea in juvenile cerebral palsy patients and they are followed up for 1 year
详细描述
This was a prospective, longitudinal analysis with 1-year follow-up of 52 children with juvenile cerebral palsy (JCP) suffering from sialorrhea enrolled from 3 tertiary pediatric neurology rehabilitation centers (two in Cairo and one in Alexandria) and subjected to repeated BoNT-A injection.
The recruitment period was between June 30, 2021, until May 1, 2022 (the last patient follow-up ended on April 30, 2023).
Intervention: 100 units of OnabotulinumtoxinA (Botox®) were injected in the parotid and submandibular glands Follow-up visits: mo 1 post-injection (for every injection session) and every 3 months thereafter
In each visit; the following efficacy variables were assessed:
Primary outcome measures: The severity and frequency of sialorrhea evaluated by Drooling Severity Scale (DSS), and Drooling Frequency Scale (DFS) and visual-analogic ratings of familial distress (VAS-FD).
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Juvenile cerebral palsy with age range (4 - 12 years)
- •Having severe drooling (DFS > 4)
- •Signing written informed consent by the legal guardians.
排除标准
- •Previous BoNT-A injection in the last three months
- •Patients receiving systemic medicine for the treatment of sialorrhea in the last 6 weeks
- •Any contraindications to treatment with BoNT
结局指标
主要结局
Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS)
时间窗: 1 year
Each patient was assigned a severity rank according to the following grades: 1, dry: never drools; 2, mild: only the lips are wet; 3, moderate: wet on the lips and chin; 4, severe: drools to the extent that clothing becomes damp; 5, profuse: clothing, hands, tray, and objects become wet. The frequency of drooling was also rated as 1, never drools; 2, occasional drooling; 3, frequent drooling; and 4, constant drooling. The final drooling score is the summed ranking across both scales together to make a combined drooling ranking from 2 to 9.
次要结局
未报告次要终点
研究者
Hatem Samir Shehata
Professor of Neurology
Cairo University