A Multi-Centre Epidemiology Study on Neonatal Seizure in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
研究概览
简要总结
A Multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain electric activity and diagnose. Other data also will be collected since first seizure until confirmed diagnosis.
详细描述
This study is designed to describe the incidence of newborn with uncontrolled seizures. Seizures can be associated with any high-risk factors during perinatal stage and diagnosed by abnormal electrical activity in the brain.
In this study researchers will use electroencephalography (EEG) to determine and monitor newborn with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur.
In addition to monitoring electrical activity of the brain, researchers will collect demographic, medical history, family, perinatal stage, birth, growth, feeding condition by medical records and questionnaire. These information will allow researchers to learn more about what high-risk factors influence the incidence of neonatal seizure in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 0~28 days;
- •Clinical diagnosed with seizure;
- •EEG diagnosed with seizure;
- •Parents who consent to their participation in the study;
排除标准
- •Parents who will not comply to the needs and the design process.
结局指标
主要结局
Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
时间窗: Participants will be followed for the duration of neonatal from birth to 28 day, an expected average of 28 days.
Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
次要结局
- EEG(In 14 Days after seizure attack)
- Neurodevelopment(Bayley Scores)(At corrected age of 18 months)
- Gene Mutation(30 days after receipt of DNA sample)
- Neurological Evaluation(GMFM-88 Scores)(At corrected age of 18 months)