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NCT Number: NCT02552511

Epidemiology Study on Neonatal Seizure

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.

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Key information

Conditions

Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Wenhao Zhou, Doctor

CONTACT

[email protected]

(+86)021-64931003

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. EEG

    Time frame: In 14 Days after seizure attack

    To measured by EEG after seizure attack.

  2. 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).

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoqiang Cheng, Doctor

CONTACT

[email protected]

Wenhao Zhou, Doctor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

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

Registry information

Official study title

A Multi-Centre Epidemiology Study on Neonatal Seizure in China

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2015
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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