Understanding and treating seizures in newborns
Gene Profiling and Individualized Treatment of Neonatal Seizure in China
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03822741 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include neonates with severe seizures or generalized epilepsy that began before one year of age, particularly those with unknown etiology.
Not a fit: Patients with seizures resulting from known causes such as trauma, infections, or metabolic disorders are unlikely to benefit from this study.
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 performed: Other studies utilizing next-generation sequencing for genetic diagnosis in epilepsy have shown promise, indicating that this approach may be effective.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Children Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wenhao Zhou, Doctor
- Email: zwhchfu@126.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.