Actively Recruiting

Age: 0 - 12Months
All Genders
ID03822741

Gene Profiling and Individualized Treatment of Neonatal Seizure in China

Led by Children's Hospital of Fudan University · Updated on 2026-03-16

2000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying genetic diagnosis and treatment strategies for neonates experiencing seizures within the first year of life, focusing particularly on those with seizure onset before one month of age. The study aims to identify genetic variants using next-generation sequencing (NGS) to better understand the causes and clinical features of neonatal and infant epilepsy. This work supports the development of personalized medicine approaches by comparing genetic and clinical data between groups based on age of seizure onset. The study involves performing genetic sequencing on neonates and infants with severe seizures or intractable epilepsy starting before one year old. The genetic tests focus on genes known to be associated with seizure disorders. The research assesses existing treatments' effects while collecting genetic data to inform future individualized therapies. There is no intervention or drug being tested; instead, this is an observational study gathering detailed genetic and clinical information. Participants will be monitored from seizure onset through up to six months afterward to evaluate seizure frequency and genetic mutation rates. The study collects data on mutation rates of common seizure genes, with genetic sequencing possibly taking up to three months to complete. Researchers will assess seizure control and treatment responses over six months to improve understanding of neonatal seizure disorders. Participation duration varies based on individual seizure onset and follow-up timing.

CONDITIONS

Brief Title

Etiology and Treatment of Neonatal Seizure

Who Can Participate

Age: 0 - 12Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe seizures in neonates or generalized epilepsy or intractable epilepsy in infancy with generalized tonic-clonic seizures
  • Seizure onset before 1 year of age
  • Epileptic syndromes or epileptic encephalopathies with unknown cause
Not Eligible

You will not qualify if you...

  • History of trauma
  • Central nervous system infections
  • Hypoxic-ischemic encephalopathy
  • Vascular events
  • Systemic infections
  • Diagnosed metabolic disorders
  • Pathogenic copy-number variants identified by array-based comparative genomic hybridization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo genetic sequencing to detect and quantify genetic variants related to neonatal seizures.

Long-term Monitoring

Duration - 6 months from seizure onset

Participants are monitored for seizure outcomes and effectiveness of existing therapeutic strategies over time.

Trial Site Locations

Total: 1 location

1

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

Loading map...

Research Team

W

Wenhao Zhou, Doctor

L

Lin Yang, 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

0

Similar Trials

A Phase IIb Dose Escalation Study of Levetiracetam for the T...

Neonatal Seizure

Actively Recruiting

5 locations

A Prospective, Open-label, Single-arm, Multi-center Pilot St...

Drug Resistant Epilepsy

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial