Epidemiology Study on Neonatal Seizure

March 16, 2023 updated by: Children's Hospital of Fudan University

A Multi-Centre Epidemiology Study on Neonatal Seizure in China

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Recruiting
        • Children Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All inpatients and Outpatients of neonates

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Exposure
Perinatal factors exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for the duration of neonatal from birth to 28 day, an expected average of 28 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopment(Bayley Scores)
Time Frame: 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).
At corrected age of 18 months
EEG
Time Frame: In 14 Days after seizure attack
To measured by EEG after seizure attack.
In 14 Days after seizure attack
Neurological Evaluation(GMFM-88 Scores)
Time Frame: 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.
At corrected age of 18 months
Gene Mutation
Time Frame: 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.
30 days after receipt of DNA sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

Second Affiliated Hospital of Wenzhou Medical University
Guangzhou Women and Children's Medical Center
Maternal and Child Health Hospital of Hubei Province
Guangzhou Medical University
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Xiamen Children's Hospital, Fujian of China
The People's Hospital of Dehong Autonomous Prefecture
Nanfang Hospital of Southern Medical University, Guangdong of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

December 30, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_NNICU6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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