Genetic testing for children with epilepsy and developmental issues in Vietnam
Genetic Investigations in Children With Developmental and Epileptic Encephalopathies in Ho Chi Minh City, Vietnam: A Collaborative, Prospective, Tertiary Care Center Study
This study is testing if advanced genetic testing can help identify the causes of epilepsy and developmental issues in children in Vietnam to improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 1 Day to 3 Years |
| Sex | All |
| Sponsor | Number 2 Children's Hospital, Ho Chi Minh City Academic / other |
| Locations | 1 site (Ho Chi Minh city, Ho Chi Minh) |
| Trial ID | NCT05722990 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of advanced genetic investigations in identifying pathogenic gene variants in children with developmental and epileptic encephalopathies at a major pediatric neurology facility in Ho Chi Minh City, Vietnam. The study will evaluate the proportion of children diagnosed through whole exome sequencing and the potential for individualized treatment adaptations based on genetic findings. By collaborating with institutions in Switzerland, the study seeks to optimize genetic testing procedures for early-onset epilepsy in Vietnam, where such practices are not yet routine.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-36 months with drug-resistant epilepsy and severe developmental delay or regression.
Not a fit: Patients with identified structural, infectious, or inflammatory causes of their symptoms will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and personalized treatment options for children suffering from severe early-onset epilepsy and developmental delays.
How similar studies have performed: Other studies have shown success with genetic investigations in similar populations, but this specific approach in Vietnam is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Drug-resistant epilepsy, either from onset, or at follow-up, according to ILAE 2010 criteria * Severe developmental delay or regression, according to paediatric neurologist evaluation (or developmental quotient \<50, if formally assessed) * Age of onset of principal symptoms (Seizures, Developmental delay): 0-36 months * Agreement to take part in the study and signed consent form Exclusion Criteria: * Patients with identified structural, infectious or inflammatory causes (such as perinatal hypoxic-ischemic encephalopathy, Cerebrovascular disorders, Sequelae of trauma or encephalitis, neurocutaneous disorders, etc...) will not be asked to take part to the study.
Where this trial is running
Ho Chi Minh city, Ho Chi Minh
- N02 Children's Hospital — Ho Chi Minh city, Ho Chi Minh, Vietnam (Recruiting)
Study contacts
- Principal investigator: Thuy-Minh-Thu NGUYEN, MD — http://www.benhviennhi.org.vn/
- Study coordinator: Thuy-Minh-Thu NGUYEN, MD
- Email: thunguyen@ump.edu.vn
- Phone: +84983966371
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.