- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07660003
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Kayseri, Tyrkiet (Türkiye), 38090
- Kayseri City Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
4) Serum sample obtainable within 24 hours of seizure onset (seizure groups) Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary Outcome Measures
Tidsramme: Within 24 hours of seizure onset
|
|
Within 24 hours of seizure onset
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Etik C.D.No:461(Kayseri CH)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .