Understanding and treating seizures in newborns
Official title: Gene Profiling and Individualized Treatment of Neonatal Seizure in China
Run by Children's Hospital of Fudan University · NCT03822741 · Data updated 2026-11-12
This study is testing how genetic information can help doctors better understand and treat seizures in newborns during their first month of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 8, 2016 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT03822741 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include neonates with severe seizures or generalized epilepsy that began before one year of age, particularly those with unknown etiology.
✕Probably not a fit
Patients with seizures resulting from known causes such as trauma, infections, or metabolic disorders are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the genetic diagnosis and treatment of neonates experiencing seizures within their first month of life. By utilizing next-generation sequencing (NGS), researchers aim to identify genetic variants associated with seizures and assess the effectiveness of current therapies. Patients are categorized based on the age of seizure onset to compare clinical and genetic features, which may lead to improved precision medicine strategies for treating neonatal epilepsy. The study addresses the challenges of molecular diagnosis in neonates and aims to enhance treatment approaches based on genetic findings.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment options for neonates suffering from seizures.
How similar studies have gone: Other studies utilizing next-generation sequencing for genetic diagnosis in epilepsy have shown promise, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe seizures in neonates or generalized epilepsy or intractable epilepsy in infancy with generalized tonic-clonic seizures, * seizures onset before 1 year of age, * epileptic syndromes/epileptic-encephalopathies with unknown etiology. Exclusion Criteria: * Patients were excluded if they had traumas, central nervous system infections, hypoxic-ischemic encephalopathy, vascular events, systemic infections, and diagnosed metabolic disorders, and pathogenic copy-number variants were identified using array-based comparative genomic hybridization (CGH).
Where it's running
-
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Wenhao Zhou, Doctor
- Email: zwhchfu@126.com
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.