The Incidence And Risk Factors Of Recurrent Febrile Seizures And Epilepsy Following Febrile Seizures

NCT06444126 | Recruiting

• 1 other identifier: 16/23-BVNĐ2
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the recurrence and development of epilepsy in children hospitalized with their first febrile seizures. The main questions it aims to answer are:

• What is the risk of recurrence after the first febrile seizure and what are the risk factors for recurrent febrile seizures in Vietnamese children?
• What is the risk of developing epilepsy later in life and what are the risk factors for developing epilepsy in Vietnamese children who have had febrile seizures?

Conditions

Febrile Seizures; Epilepsy in Children

Outcome Measures

Primary Outcomes (2)

• The incidence and risk factors of the recurrence of febrile seizures

  Following the initial interview, parents were contacted every three months to determine whether their child had experienced any further seizures and the circumstances under which they occurred. If a febrile seizure recurs or an afebrile seizure occurs, parents can report it immediately and directly to the investigator.

  2 years

• The incidence and risk factors of the epilepsy following febrile seizures

  We considered a seizure unprovoked if there were no acute precipitating circumstances to which the seizure could reasonably be attributed. According to the ILAE practical clinical definition from 2014, epilepsy is characterized by having two unprovoked seizures that are more than 24 hours apart

  2 years

Study Arms (1)

Initial Febrile Seizures

The initial cohort included children hospitalized with their first febrile seizure

Eligibility Criteria

• Age: 1 Month - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children, who had a diagnosis of first febrile seizure at discharge from the General Pediatric Department and Neurology Department of Children's Hospital 2

You may qualify if:

• Children had a diagnosis of first febrile seizure based on the definition of the International League Against Epilepsy (ILAE) in 1993. That was a seizure occurring in childhood after one month of age associated with a febrile illness not caused by an infection of the central nervous system, without previous neonatal seizures or a previous unprovoked seizure, and not meeting the criteria for other acute symptomatic seizures. Fever is clinically a temperature of at least 38°C by any method as recorded either in the emergency department, outpatient clinics, or as noted in the medical history, as well as measured upon admission to the inpatient departments.
• Patients were between 1 month and 8 years of age
• Agreement from parents with written informed consent

You may not qualify if:

• Febrile paroxysmal events were atypical for seizures
• Underlying neurological conditions that increase the likelihood of epilepsy
• Unwillingness to return for follow-up

Sponsors & Collaborators

• Pham Ngoc Thach University of Medicine: lead

Study Sites (1)

Children's Hospital 2

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Seizures, Febrile

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Kim Tang, M.D, Ph.D

  Pham Ngoc Thach University of Medicine

  STUDY DIRECTOR

• Anh Hieu Bui, M.D

  Pham Ngoc Thach University of Medicine

  PRINCIPAL INVESTIGATOR

• Van Khanh Le, M.D, Ph.D

  Pham Ngoc Thach University of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anh Hieu Bui, M.D.

CONTACT

+84772962612; anhbh@pnt.edu.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer - Researcher

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: March 15, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

VN (1)