Febrile SeizuresNCT07660003
8-OHdG and Oxidative Stress in Febrile Seizures
An observational study of Febrile Seizures and Oxidative Stress, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 72 months
- Conditions the study is for
- Febrile Seizures, Oxidative Stress, Oxidative DNA Damage
- What is being tested?
- Group 2 SFC and Group 3 CFC
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 72 months
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Febrile Seizures, Oxidative Stress, Oxidative DNA Damage
- Being tested
- Group 1 Health Controls, Group 2 SFC, Group 3 CFC
- Keywords
- 8-OHdG, Febrile seizure, Simple febrile seizure, Complex febrile seizure, Oxidative DNA damage, Oxidative stress
- Medical subject headings
- Seizures, Febrile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Health ControlsDiagnostic test
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 SFCDiagnostic test
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 CFCDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Health Controls | Healthy controls (afebrile) n:57 Serum 8-OHdG measurement Receives: Diagnostic Test: Group 1 Health Controls | |
| Group 2 SFC | Simple febrile seizure (SFC) n:50 Serum 8-OHdG measurement Receives: Diagnostic Test: Group 2 SFC | |
| Group 3 CFC | Complex febrile seizure (CFC) n:49 Serum 8-OHdG measurement Receives: Diagnostic Test: Group 3 CFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
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
Measured: Time Frame: Within 24 hours of seizure onset (single measurement)
Secondary outcomes (1)
Secondary Outcome Measures
- 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)
Measured: Within 24 hours of seizure onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2021
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Febrile SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660003
- Sponsor's protocol ID
- Etik C.D.No:461(Kayseri CH)
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39395948Poorshiri 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.
PubMed 36745963Fuchs 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.
PubMed 37767398Lewis 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.
PubMed 38606600Akarsu 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.
PubMed 17509462
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07660003
- Acronym / sponsor ID
- Etik C.D.No:461(Kayseri CH)
- Conditions
- Febrile Seizures, Oxidative Stress, Oxidative DNA Damage
- Keywords
- 8-OHdG, Febrile seizure, Simple febrile seizure, Complex febrile seizure, Oxidative DNA damage, Oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Health Controls | – | Diagnostic Test: Group 1 Health ControlsHealthy controls (afebrile) n:57 Serum 8-OHdG measurement |
| Group 2 SFC | – | Diagnostic Test: Group 2 SFCSimple febrile seizure (SFC) n:50 Serum 8-OHdG measurement |
| Group 3 CFC | – | Diagnostic Test: Group 3 CFCComplex febrile seizure (CFC) n:49 Serum 8-OHdG measurement |
Who may qualify
- Ages
- 6 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 Health ControlsSingle 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 test | Group 1 Health Controls |
| Group 2 SFCSingle 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 test | Group 2 SFC |
| Group 3 CFCSingle 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. | Diagnostic test | Group 3 CFC |
Primary outcome
Primary Outcome Measure
Time frame: 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
1 secondary outcome
Secondary Outcome Measures
Time frame: Within 24 hours of seizure onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Results publication: PubMed 39395948Wang 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.
- Results publication: PubMed 36745963Poorshiri 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.
- Results publication: PubMed 37767398Fuchs 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.
- Results publication: PubMed 38606600Lewis 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.
- Results publication: PubMed 17509462Akarsu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Seizures and Oxidative Stress, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: Time Frame: Within 24 hours of seizure onset (single measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07660003, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.