NCT07660003

Brief Summary

This prospective case-control study investigates whether serum 8-hydroxy-2'-deoxyguanosine (8-OHdG), an established biomarker of reactive oxygen species-mediated DNA oxidation, is elevated in children with febrile seizures compared with healthy children, and whether it differs between simple and complex febrile seizure subtypes. Children presenting with a febrile seizure and age-matched healthy controls have serum 8-OHdG measured within 24 hours of seizure onset, alongside routine inflammatory markers (white-cell count, C-reactive protein) and haemoglobin. The primary aim is to determine whether acute oxidative DNA damage is detectable after febrile seizures and whether 8-OHdG levels distinguish simple from complex subtypes. The study is exploratory and hypothesis-generating; it is not designed to establish 8-OHdG as a clinically applicable diagnostic biomarker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 16, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

8-OHdGFebrile seizureSimple febrile seizureComplex febrile seizureOxidative DNA damageOxidative stress

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Title: Serum 8-hydroxy-2'-deoxyguanosine (8-OHdG) concentration Description: Serum 8-OHdG concentration (ng/mL), quantified by ELISA, compared among children with simple febrile seizure, complex febrile seizure, and healthy controls, to determine whether acute oxidative DNA damage differs across these groups. Time Frame: Within 24 hours of seizure onset (single measurement) Unit of Measure: ng/mL

    Time Frame: Within 24 hours of seizure onset (single measurement)

Secondary Outcomes (1)

  • Secondary Outcome Measures

    Within 24 hours of seizure onset

Study Arms (3)

Group 1 Health Controls

Healthy controls (afebrile) n:57 Serum 8-OHdG measurement

Diagnostic Test: Group 1 Health Controls

Group 2 SFC

Simple febrile seizure (SFC) n:50 Serum 8-OHdG measurement

Diagnostic Test: Group 2 SFC

Group 3 CFC

Complex febrile seizure (CFC) n:49 Serum 8-OHdG measurement

Diagnostic Test: Group 3 CFC

Interventions

Single venous blood sample obtained from each participant; serum 8-hydroxy-2'-deoxyguanosine (8-OHdG) was measured by enzyme-linked immunosorbent assay (ELISA) within 24 hours of seizure onset. This was an observational measurement only; no therapeutic intervention was administered.

Group 1 Health Controls
Group 2 SFCDIAGNOSTIC_TEST

Single venous blood sample obtained from each participant; serum 8-hydroxy-2'-deoxyguanosine (8-OHdG) was measured by enzyme-linked immunosorbent assay (ELISA) within 24 hours of seizure onset. This was an observational measurement only; no therapeutic intervention was administered.

Group 2 SFC
Group 3 CFCDIAGNOSTIC_TEST

Single venous blood sample obtained from each participant; serum 8-hydroxy-2'-deoxyguanosine (8-OHdG) was measured by ELISA within 24 hours of seizure onset. The same measurement was performed in all three groups (healthy controls, simple febrile seizure, and complex febrile seizure). This was an observational measurement only; no therapeutic intervention was administered.

Group 3 CFC

Eligibility Criteria

Age6 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 6 to 72 months presenting to the paediatric emergency department of Kayseri City Training and Research Hospital (Kayseri, Türkiye). Three groups: simple febrile seizure, complex febrile seizure, and age- and sex-matched healthy controls. Participants were enrolled prospectively by convenience sampling from consecutive eligible admissions.

You may qualify if:

  • Age between 6 and 72 months
  • Presentation with a febrile seizure (simple or complex) to the paediatric emergency department, OR healthy age- and sex-matched child (control group) 3) For seizure groups: a seizure occurring in the context of fever, meeting clinical criteria for simple or complex febrile seizure
  • \) Serum sample obtainable within 24 hours of seizure onset (seizure groups) Written informed consent provided by a parent or legal guardian

You may not qualify if:

  • Central nervous system (CNS) infection (e.g., meningitis, encephalitis)
  • Known epilepsy or prior afebrile seizures
  • Neurodevelopmental delay
  • Chronic systemic illness
  • Use of antioxidant supplements within the preceding 3 months
  • Incomplete clinical or laboratory data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, 38090, Turkey (Türkiye)

Location

Related Publications (5)

  • Wang Q, Sun W, Zhao J, Tong L, Li B. Development and validation of a nomogram for the estimation of the prognosis of patients presenting with a febrile seizure. BMC Pediatr. 2024 Oct 12;24(1):655. doi: 10.1186/s12887-024-05132-z.

  • Poorshiri B, Barzegar M, Afghan M, Shiva S, Shahabi P, Golchinfar Z, Yousefi Nodeh HR, Raeisi S. The effects of ketogenic diet on beta-hydroxybutyrate, arachidonic acid, and oxidative stress in pediatric epilepsy. Epilepsy Behav. 2023 Mar;140:109106. doi: 10.1016/j.yebeh.2023.109106. Epub 2023 Feb 4.

  • Fuchs M, Viel C, Lehto A, Lau H, Klein J. Oxidative stress in rat brain during experimental status epilepticus: effect of antioxidants. Front Pharmacol. 2023 Sep 12;14:1233184. doi: 10.3389/fphar.2023.1233184. eCollection 2023.

  • Lewis DV, Voyvodic J, Shinnar S, Chan S, Bello JA, Moshe SL, Nordli DR Jr, Frank LM, Pellock JM, Hesdorffer DC, Xu Y, Shinnar RC, Seinfeld S, Epstein LG, Masur D, Gallentine W, Weiss E, Deng X, Sun S; FEBSTAT Study Team. Hippocampal sclerosis and temporal lobe epilepsy following febrile status epilepticus: The FEBSTAT study. Epilepsia. 2024 Jun;65(6):1568-1580. doi: 10.1111/epi.17979. Epub 2024 Apr 12.

  • Akarsu S, Yilmaz S, Ozan S, Kurt A, Benzer F, Gurgoze MK. Effects of febrile and afebrile seizures on oxidant state in children. Pediatr Neurol. 2007 May;36(5):307-11. doi: 10.1016/j.pediatrneurol.2007.01.010.

MeSH Terms

Conditions

Seizures, Febrile

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the published results (serum 8-OHdG concentrations, demographic and clinical variables, and laboratory parameters) are available from the corresponding author on reasonable request. Data will be shared with qualified researchers whose proposed use has been approved and for purposes consistent with the original ethics approval; a data-use agreement may be required.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will become available after publication of the main results and will remain accessible for 5 years thereafter, upon reasonable request to the corresponding author.
Access Criteria
Qualified researchers may request access by contacting the corresponding author. Requests will be evaluated for scientific merit and consistency with the original ethics approval, and a data-use agreement may be required before de-identified data are shared.

Locations