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8-OHdG and Oxidative Stress in Febrile Seizures

Serum 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) and Oxidative DNA Damage in Children With Simple and Complex Febrile Seizures: An Exploratory Prospective Case-Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07660003
Enrollment
156
Registered
2026-06-22
Start date
2021-09-01
Completion date
2022-12-30
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Seizures, Oxidative DNA Damage, Oxidative Stress

Keywords

8-OHdG, Febrile seizure, Simple febrile seizure, Complex febrile seizure, Oxidative DNA damage, Oxidative stress

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.

Detailed description

Febrile seizures are the most common convulsive events of early childhood. Oxidative stress contributes to seizure-induced neuronal injury, but clinical data on oxidative DNA damage across febrile seizure subtypes are limited. This single-centre, prospective case-control study was conducted at the paediatric emergency department of Kayseri City Training and Research Hospital between September and December 2021. Participants were allocated to three groups: children with a simple febrile seizure, children with a complex febrile seizure, and age- and sex-matched healthy controls. After enrolment, a single venous blood sample was obtained from each child within 24 hours of seizure onset (or at presentation for controls). Serum was separated and stored at -80 °C until analysis. Serum 8-hydroxy-2'-deoxyguanosine (8-OHdG) was quantified by a commercial enzyme-linked immunosorbent assay (ELISA), with all samples measured in duplicate. Routine laboratory parameters-white-cell count, haemoglobin, and C-reactive protein-and body temperature were recorded concurrently. Serum 8-OHdG concentrations were compared among the three groups, and the ability of 8-OHdG to discriminate febrile seizure subtypes was explored. Pre-specified subgroup analyses examined complex febrile seizure patients with versus without febrile status epilepticus, and the relationship between 8-OHdG and inflammatory markers. The analysis was framed as exploratory; the study was not powered to validate 8-OHdG as a diagnostic test.

Interventions

DIAGNOSTIC_TESTGroup 1 Health Controls

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.

DIAGNOSTIC_TESTGroup 2 SFC

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.

DIAGNOSTIC_TESTGroup 3 CFC

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.

Sponsors

Kayseri City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 72 Months
Healthy volunteers
No

Inclusion criteria

1. Age between 6 and 72 months 2. 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 4\) Serum sample obtainable within 24 hours of seizure onset (seizure groups) Written informed consent provided by a parent or legal guardian

Exclusion criteria

1. Central nervous system (CNS) infection (e.g., meningitis, encephalitis) 2. Known epilepsy or prior afebrile seizures 3. Neurodevelopmental delay 4. Chronic systemic illness 5. Use of antioxidant supplements within the preceding 3 months 6. Incomplete clinical or laboratory data

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome MeasureTime Frame: Within 24 hours of seizure onset (single measurement)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

Secondary

MeasureTime frameDescription
Secondary Outcome MeasuresWithin 24 hours of seizure onset* Diagnostic discrimination of serum 8-OHdG (ROC AUC) - Area under the ROC curve for serum 8-OHdG in discriminating febrile seizure subtypes from controls. (Time Frame: Within 24 hours of seizure onset) * 8-OHdG in febrile status epilepticus (FSE) subgroup - Comparison of serum 8-OHdG between CFC patients with vs. without FSE. (Time Frame: Within 24 hours of seizure onset) * Association with inflammatory markers - Relationship between serum 8-OHdG and white-cell count, C-reactive protein, and haemoglobin. (Time Frame: Within 24 hours of seizure onset)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026