Risk Factors for Drug-Resistant Epilepsy in Children (PED-DRE)

July 20, 2026 updated by: Hong Tang, Pham Ngoc Thach University of Medicine

Risk Factors for Drug-Resistant Epilepsy in Children: A Prospective Cohort Study

This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Hồ Chí Minh
      • Ho Chi Minh City, Hồ Chí Minh, Vietnam
        • Children's Hospital 1, Ho Chi Minh City, Vietnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with epilepsy receiving care at Children's Hospital 1, Ho Chi Minh City, Vietnam.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No Intervention: Observational Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Drug-Resistant Epilepsy
Time Frame: Minimum 12 months after initiation of antiseizure medication
Development of drug-resistant epilepsy according to the International League Against Epilepsy definition after failure of two appropriately selected and tolerated antiseizure medications.
Minimum 12 months after initiation of antiseizure medication

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to drug-resistant epilepsy
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pham Ngoc Thach University of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-PNTU-2025-250510602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on No Intervention: Observational Cohort

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe