Risk Factors for Drug-Resistant Epilepsy in Children (PED-DRE)
Risk Factors for Drug-Resistant Epilepsy in Children: A Prospective Cohort Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Epilepsy is one of the most common neurological disorders in childhood. Approximately one-third of pediatric patients eventually develop drug-resistant epilepsy despite appropriate antiseizure medication treatment. Early identification of children at high risk of drug resistance may facilitate timely referral for advanced therapies including epilepsy surgery, ketogenic diet, or neuromodulation.
This prospective cohort study aims to identify independent predictors of drug-resistant epilepsy in children treated at Children's Hospital 1, Ho Chi Minh City, Vietnam. Clinical characteristics, electroencephalography findings, neuroimaging, genetic testing, metabolic investigations, treatment response, and developmental outcomes will be prospectively collected.
Cox proportional hazards regression will be used to identify independent predictors of drug resistance. Machine learning models including logistic regression and random forest will subsequently be developed and internally validated to predict drug-resistant epilepsy.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Hồ Chí Minh
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Ho Chi Minh City, Hồ Chí Minh, Vietnam
- Children's Hospital 1, Ho Chi Minh City, Vietnam
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Children younger than 16 years, including neonates.
- Diagnosed with epilepsy according to International League Against Epilepsy criteria.
- Receiving treatment or follow-up at Children's Hospital 1.
- Parent or legal guardian provides informed consent.
- Expected follow-up of at least 12 months.
Exclusion Criteria:
- Poor treatment adherence.
- Insufficient baseline data.
- Lost to follow-up.
- Psychogenic nonepileptic seizures.
- Severe systemic illness interfering with antiseizure medication.
- Acute symptomatic seizures.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Children with newly diagnosed epilepsy
Children with newly diagnosed epilepsy enrolled in a prospective observational cohort and followed longitudinally to determine the development of drug-resistant epilepsy and identify predictors of drug resistance.
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Participants will receive standard clinical care as determined by their treating physicians.
No intervention is assigned by the study protocol.
The study is observational and does not influence treatment decisions.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Development of Drug-Resistant Epilepsy
Tidsramme: Minimum 12 months after initiation of antiseizure medication
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Development of drug-resistant epilepsy according to the International League Against Epilepsy definition after failure of two appropriately selected and tolerated antiseizure medications.
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Minimum 12 months after initiation of antiseizure medication
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Time to drug-resistant epilepsy
Tidsramme: Up to 36 months
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Up to 36 months
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-PNTU-2025-250510602
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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