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8-OHdG and Oxidative Stress in Febrile Seizures

3 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

156

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Group 1 Health Controls
Healthy controls (afebrile) n:57 Serum 8-OHdG measurement
Test diagnostique: Group 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.
Group 2 SFC
Simple febrile seizure (SFC) n:50 Serum 8-OHdG measurement
Test diagnostique: Group 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.
Group 3 CFC
Complex febrile seizure (CFC) n:49 Serum 8-OHdG measurement
Test diagnostique: Group 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Primary Outcome Measure
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Secondary Outcome Measures
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kayseri City Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2021

Achèvement primaire (Réel)

30 juin 2022

Achèvement de l'étude (Réel)

30 décembre 2022

Dates d'inscription aux études

Première soumission

16 juin 2026

Première soumission répondant aux critères de contrôle qualité

16 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juillet 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Etik C.D.No:461(Kayseri CH)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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