Risk Factors for Drug-Resistant Epilepsy in Children (PED-DRE)
Risk Factors for Drug-Resistant Epilepsy in Children: A Prospective Cohort Study
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Hồ Chí Minh
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Ho Chi Minh City, Hồ Chí Minh, 베트남
- Children's Hospital 1, Ho Chi Minh City, Vietnam
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
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디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Development of Drug-Resistant Epilepsy
기간: 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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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Time to drug-resistant epilepsy
기간: Up to 36 months
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Up to 36 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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