A Multi-Centre Epidemiology Study on Neonatal Seizure in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Seizures
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 1400
- Locations
- 1
- Primary Endpoint
- Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age from 0\~28 days;
- •Clinical diagnosed with seizure;
- •EEG diagnosed with seizure;
- •Parents who consent to their participation in the study;
Exclusion Criteria
- •Parents who will not comply to the needs and the design process.
Outcomes
Primary Outcomes
Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
Time Frame: 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.
Secondary Outcomes
- 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)