Seizures
Conditions
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.
Interventions
None listed
Sponsors
Xiamen Children's Hospital, Fujian of China
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Guangzhou Women and Children's Medical Center
Second Affiliated Hospital of Wenzhou Medical University
Maternal and Child Health Hospital of Hubei Province
The People's Hospital of Dehong Autonomous Prefecture
Guangzhou Medical University
Nanfang Hospital of Southern Medical University, Guangdong of China
Children's Hospital of Fudan University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status. | 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
| Measure | Time frame | Description |
|---|---|---|
| EEG | In 14 Days after seizure attack | To measured by EEG after seizure attack. |
| Neurodevelopment(Bayley Scores) | At corrected age of 18 months | To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSID) and gain incidence of MDI\<70(Severe) or MDI\<85(Moderate). |
| Neurological Evaluation(GMFM-88 Scores) | At corrected age of 18 months | To gain changes in standardized gross motor function using GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales, lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0\ 100 , Higher value means better gross motor function).malformation using genomic methods. |
| Gene Mutation | 30 days after receipt of DNA sample | To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using genomic methods. |
Countries
China
Contacts
Primary ContactWenhao Zhou, Doctor
Backup ContactGuoqiang Cheng, Doctor
Outcome results
None listed