NL-OMON50942尚未招募不适用
Ethanol submandibular duct ligation for drooling in children with neurodisabilities - Ethanol 2-duct ligation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •1. Moderate to severe drooling indicated by Drooling Frequency Score >= 3 or
- •Drooling 370 Severity Score >= 2. 371
- •2. Aged 10 years and older. 372
- •3. Cerebral palsy or any other non-progressive neurodevelopmental disability.
- •4. Contra-indications for a SMDR, or rejection towards a SMDR by patient or
- •caregivers* 374
- •5. Ability and willingness to follow the study protocol and attend the 8 and
- •32-weeks vis-375 its. 376
- •6. Written and informed consent from caregivers, and when appropriate, oral
- •consent 377 from the child.
排除标准
- •1. Medical history of salivary gland abnormalities like ductal stenosis,
- •2. Previous submandibular salivary gland surgery, or other contraindications
- •for surgery 385 or general anesthesia. 386
- •3. Recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection 387
- •4. Simultaneous alternative treatment for drooling.
研究者
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