Epidemiology Study on Neonatal Seizure
ConditionSeizures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 28
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 0~28 days;
Clinical diagnosed with seizure;
EEG diagnosed with seizure;
Parents who consent to their participation in the study;
Disqualifiers
Parents who will not comply to the needs and the design process.
Trial population
All inpatients and Outpatients of neonates
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,400 Participants
are grouped into 1 trial groupGroup A: Exposure
Trial outcomes
Primary outcomes
1
Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
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.Secondary outcomes
1
EEG
To measured by EEG after seizure attack.
Time frame
In 14 Days after seizure attack2
Neurodevelopment(Bayley Scores)
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).
Time frame
At corrected age of 18 months3
Neurological Evaluation(GMFM-88 Scores)
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.
Time frame
At corrected age of 18 months4
Gene Mutation
To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using genomic methods.
Time frame
30 days after receipt of DNA sampleSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Xiamen Children's Hospital, Fujian of China
Collaborator
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Guangzhou Women and Children's Medical Center
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Maternal and Child Health Hospital of Hubei Province
Collaborator
The People's Hospital of Dehong Autonomous Prefecture
Collaborator
Guangzhou Medical University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Source ClinicalTrials.gov