- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Kayseri, Tyrkia (Türkiye), 38090
- Kayseri City Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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 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
|
|
Within 24 hours of seizure onset
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Etik C.D.No:461(Kayseri CH)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .