Actively Recruiting

Age: 0 - 28Days
All Genders
ID02552511

A Multi-Centre Epidemiology Study on Neonatal Seizure in China

Led by Children's Hospital of Fudan University · Updated on 2025-09-05

1400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Children's Hospital of Fudan University

Lead Sponsor

X

Xiamen Children's Hospital, Fujian of China

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to describe how often new seizures start or are newly diagnosed in newborn babies up to 28 days old. It focuses on babies with uncontrolled seizures, which can be linked to high-risk factors during the time around birth. Researchers study abnormal electrical activity in the brain to understand these seizures better. To do this, the study uses electroencephalography (EEG) to monitor and record brain electrical activity in newborns suspected of having seizures. Along with EEG recordings, information about the babies' demographics, medical history, family background, birth details, growth, and feeding is collected through medical records and questionnaires. This helps identify factors that may influence seizure occurrence in newborns. Participants will be followed from birth until 28 days old to record seizure incidence and monitor brain activity using EEG within 14 days after any seizure. At 18 months corrected age, neurodevelopment and neurological function are assessed using specific scoring systems. Genetic testing is also done within 30 days of DNA sample collection. The study collects detailed information to better understand seizure risks and outcomes in newborns.

CONDITIONS

Brief Title

Epidemiology Study on Neonatal Seizure

Who Can Participate

Age: 0 - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 0 to 28 days
  • Clinical diagnosis of seizure
  • EEG diagnosis of seizure
  • Parents who consent to participation in the study
Not Eligible

You will not qualify if you...

  • Parents who will not comply with the study requirements and design process

AI-Screening

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Your Study Journey

Screening

Duration - Up to 28 days from birth

Participants are screened for eligibility to participate in the trial.

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Diagnostic Evaluation

Duration - Within 14 days after seizure attack

Participants undergo EEG to determine and monitor uncontrolled or suspected seizures, along with collection of medical records and questionnaires about demographic, family, perinatal, birth, growth, and feeding conditions.

1 to 2 visits depending on seizure occurrence

Long-term Monitoring

Duration - Up to 18 months after birth

Participants are followed to observe neurodevelopment and neurological status at corrected age of 18 months, including Bayley Scores and GMFM-88 assessments, as well as gene mutation analysis from DNA samples.

1 visit at corrected age of 18 months and 1 visit about 30 days after DNA sample collection

Trial Site Locations

Total: 1 location

1

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

W

Wenhao Zhou, Doctor

G

Guoqiang Cheng, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Seizures, encephalopathy, and vaccines: experience in the National Vaccine Injury Compensation Program.

Tarannum M Lateef, Rosemary Johann-Liang, Himanshu Kaulas...

https://pubmed.ncbi.nlm.nih.gov/25477158

Electrographic seizures after convulsive status epilepticus in children and young adults: a retrospective multicenter study.

Iván Sánchez Fernández, Nicholas S Abend, Daniel H Arndt...

https://pubmed.ncbi.nlm.nih.gov/24161223

Apgar score of 0 at 5 minutes and neonatal seizures or serious neurologic dysfunction in relation to birth setting.

Amos Grünebaum, Laurence B McCullough, Katherine J Sapra...

https://pubmed.ncbi.nlm.nih.gov/23791692