Risk Factors for Drug-Resistant Epilepsy in Children: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Development of Drug-Resistant Epilepsy
研究概览
简要总结
This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy.
详细描述
Epilepsy is one of the most common neurological disorders in childhood. Approximately one-third of pediatric patients eventually develop drug-resistant epilepsy despite appropriate antiseizure medication treatment. Early identification of children at high risk of drug resistance may facilitate timely referral for advanced therapies including epilepsy surgery, ketogenic diet, or neuromodulation.
This prospective cohort study aims to identify independent predictors of drug-resistant epilepsy in children treated at Children's Hospital 1, Ho Chi Minh City, Vietnam. Clinical characteristics, electroencephalography findings, neuroimaging, genetic testing, metabolic investigations, treatment response, and developmental outcomes will be prospectively collected.
Cox proportional hazards regression will be used to identify independent predictors of drug resistance. Machine learning models including logistic regression and random forest will subsequently be developed and internally validated to predict drug-resistant epilepsy.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children younger than 16 years, including neonates.
- •Diagnosed with epilepsy according to International League Against Epilepsy criteria.
- •Receiving treatment or follow-up at Children's Hospital
- •Parent or legal guardian provides informed consent.
- •Expected follow-up of at least 12 months.
排除标准
- •Poor treatment adherence.
- •Insufficient baseline data.
- •Lost to follow-up.
- •Psychogenic nonepileptic seizures.
- •Severe systemic illness interfering with antiseizure medication.
- •Acute symptomatic seizures.
研究组 & 干预措施
Children with newly diagnosed epilepsy
Children with newly diagnosed epilepsy enrolled in a prospective observational cohort and followed longitudinally to determine the development of drug-resistant epilepsy and identify predictors of drug resistance.
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Development of Drug-Resistant Epilepsy
时间窗: Minimum 12 months after initiation of antiseizure medication
Development of drug-resistant epilepsy according to the International League Against Epilepsy definition after failure of two appropriately selected and tolerated antiseizure medications.
次要结局
- Time to drug-resistant epilepsy(Up to 36 months)
研究者
Hong Tang
Principal Investigator
Pham Ngoc Thach University of Medicine