Epidemiology Study on Neonatal Seizure

Recruiting

• Conditions: Seizures

• Registration Number: NCT02552511
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China