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8-OHdG and Oxidative Stress in Febrile Seizures

3. juli 2026 oppdatert av: Kayseri City Hospital

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

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

156

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group 1 Health Controls
Healthy controls (afebrile) n:57 Serum 8-OHdG measurement
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
Simple febrile seizure (SFC) n:50 Serum 8-OHdG measurement
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 3 CFC
Complex febrile seizure (CFC) n:49 Serum 8-OHdG measurement
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Outcome Measure
Tidsramme: Time 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

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary Outcome Measures
Tidsramme: Within 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)
Within 24 hours of seizure onset

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

1. september 2021

Primær fullføring (Faktiske)

30. juni 2022

Studiet fullført (Faktiske)

30. desember 2022

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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