Febrile ConvulsionNCT07463222
Neuroendocrine Response in Pediatric Febrile Seizures
An observational study of Febrile Convulsion and Neuroendocrine Stress Response, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Febrile seizures are the most common seizure type in early childhood and usually occur during febrile illnesses. Although most febrile seizures are benign, the biological stress response during seizures is not fully understood. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Febrile Convulsion, Neuroendocrine Stress Response, Fever
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes children aged 6 months to 5 years presenting with febrile seizures and an age-matched febrile control group without seizures, enrolled prospectively in a pediatric emergency department. The study evaluates differences in acute neuroendocrine hormone levels (thyroxine [T4], epinephrine, and norepinephrine) and their associations with seizure characteristics and short-term hospital outcomes.
Who may be able to join
- Children aged 6 months to 5 years presenting to the pediatric emergency department with fever (documented at presentation or reported by caregiver within the preceding 24 hours).
- Case group: febrile seizure occurring in the context of a febrile illness.
- Control group: febrile illness without seizure, selected to be age-matched to cases (e.g., within ±6 months).
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Suspected or confirmed central nervous system infection (e.g., meningitis, encephalitis).
- Prior diagnosis of epilepsy or history of afebrile seizures.
- Seizures attributable to acute metabolic derangements at presentation (e.g., significant hypoglycemia, clinically relevant electrolyte disturbances).
- Known thyroid disease or use of thyroid hormone/antithyroid medications.
- Known adrenal disorders or use of systemic catecholamine infusions at enrollment.
- Major chronic neurologic disorders or acute head trauma.
- Inability to obtain blood samples within protocol-defined time windows.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University Hospital
Aydin, Aydın, 09010
Aykut Çağlar, MD, +905303337877, aykut.caglar@adu.edu.tr
Murat Ayar, MD
About this study
Official title: Febrile Seizures in Children: Association of Thyroxine (T4), Epinephrine, and Norepinephrine Levels With Seizure Characteristics and Hospital Outcomes-A Prospective Controlled Observational Study
Febrile seizures are the most common seizure type in early childhood and usually occur during febrile illnesses. Although most febrile seizures are benign, the biological stress response during seizures is not fully understood. In particular, changes in thyroid hormones and stress-related hormones released by the sympathetic nervous system may play a role in seizure characteristics and clinical outcomes.
This prospective observational study aims to evaluate the neuroendocrine response in children presenting with febrile seizures by measuring serum thyroxine (T4), epinephrine, and norepinephrine levels. These measurements will be obtained during the acute phase after seizure cessation and compared with levels measured at recovery and with febrile children without seizures.
Read more
The study will examine the relationship between neuroendocrine marker levels and seizure characteristics such as seizure duration and recurrence, as well as clinical outcomes including length of hospital stay and need for pediatric intensive care unit admission.
By improving understanding of the hormonal stress response associated with febrile seizures, this study aims to contribute to the knowledge of seizure pathophysiology in childhood and may help identify biological factors associated with more severe clinical courses.
Read the detailed description
Febrile seizures represent a common pediatric neurological emergency and are triggered by fever-related systemic stress rather than primary epileptic pathology. Acute febrile seizures are accompanied by activation of the hypothalamic-pituitary-thyroid axis and the sympathetic-adrenal system, resulting in measurable changes in circulating thyroid hormones and catecholamines. However, the magnitude and clinical relevance of this neuroendocrine response remain incompletely characterized.
This study is designed as a prospective, observational, case-control investigation conducted in a pediatric emergency department setting. Children aged 6 months to 5 years presenting with febrile seizures will be enrolled as the case group. An age-matched control group will consist of febrile children without seizures. Participants will not be assigned to any intervention, and all clinical management will follow standard care practices.
In the febrile seizure group, blood samples for measurement of serum thyroxine (T4), epinephrine, and norepinephrine will be obtained within 30 minutes after seizure cessation to capture the acute neuroendocrine stress response. Additional samples will be collected prior to hospital discharge to assess recovery-phase hormone levels. In the control group, blood samples will be collected during the febrile episode at the time of clinical evaluation. All laboratory analyses will be performed using validated methods under standardized conditions.
Clinical data collected will include demographic characteristics, fever features, seizure type and duration, recurrence during hospitalization, treatment administered, length of hospital stay, and requirement for pediatric intensive care unit admission. The primary objective is to evaluate associations between acute-phase neuroendocrine marker levels and seizure characteristics, particularly seizure duration and recurrence. Secondary objectives include comparisons between febrile seizure patients and febrile controls, as well as associations between hormone levels and clinical outcomes.
Statistical analyses will include descriptive methods, group comparisons using parametric or nonparametric tests as appropriate, correlation analyses, and multivariable regression models adjusting for relevant confounders such as age, sex, peak temperature, seizure type, and treatment exposure. The study aims to provide mechanistic insight into the neuroendocrine stress response associated with febrile seizures and to explore its potential relationship with disease severity and short-term outcomes.
- Conditions
- Febrile Convulsion, Neuroendocrine Stress Response, Fever
- Keywords
- Fever, Febrile seizure, Neuroendocrine response, Pediatric emergency, Child, Thyroxine, Epinephrine, Norepinephrine
- Medical subject headings
- Seizures, Febrile, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Febrile Seizure Patients | Children aged 6 months to 5 years presenting with febrile seizures who are enrolled prospectively. Blood samples are obtained within 30 minutes after seizure cessation to assess acute neuroendocrine response, including thyroxine (T4), epinephrine, and norepinephrine levels. Additional samples are collected prior to hospital discharge. Clinical data including seizure characteristics, recurrence, length of hospital stay, and need for pediatric intensive care unit admission are recorded. No experimental intervention is administered. | |
| Febrile Controls | Age-matched febrile children without seizures enrolled as the control cohort. Blood samples are obtained during the febrile episode to measure thyroxine (T4), epinephrine, and norepinephrine levels. Clinical data related to fever characteristics are collected for comparison with the febrile seizure cohort. No experimental intervention is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in acute neuroendocrine hormone levels between febrile seizure patients and febrile controls
The difference in serum thyroxine (T4), epinephrine, and norepinephrine levels measured during the acute phase between children presenting with febrile seizures and age-matched febrile children without seizures.
Measured: Baseline (during the emergency department presentation)
Secondary outcomes (3)
Association between neuroendocrine hormone levels and seizure duration
The association between acute-phase serum thyroxine (T4), epinephrine, and norepinephrine levels and seizure duration (in minutes) in children presenting with febrile seizures.
Measured: Baseline (during the index febrile seizure event)
Association between neuroendocrine hormone levels and hospital length of stay
The association between acute-phase serum thyroxine (T4), epinephrine, and norepinephrine levels and total hospital length of stay in children presenting with febrile seizures.
Measured: From hospital admission through discharge (up to 7 days)
Association between neuroendocrine hormone levels and pediatric intensive care unit admission
The association between acute-phase serum thyroxine (T4), epinephrine, and norepinephrine levels and the requirement for pediatric intensive care unit (PICU) admission in children presenting with febrile seizures.
Measured: During the index hospitalization (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Febrile ConvulsionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Çağlar, MD, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463222
- Sponsor's protocol ID
- ADUPEDFSTEN
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asami T, Sasagawa F, Kyo S, Asami K, Uchiyama M. Incidence of febrile convulsions in children with congenital hypothyroidism. Acta Paediatr. 1998 Jun;87(6):623-6. doi: 10.1080/080352598750014003.
PubMed 9686652Thebault-Dagher F, Lafontaine MP, Knoth IS, Deguire F, Sheppard E, Cook R, Lagace M, Gravel J, Lupien S, Lippe S. Febrile seizures and increased stress sensitivity in children: How it relates to seizure characteristics. Epilepsy Behav. 2019 Jun;95:154-160. doi: 10.1016/j.yebeh.2019.03.022. Epub 2019 May 3.
PubMed 31059921Ladd JM, Sabsabi B, von Oettingen JE. Thyroid Storm in a Toddler Presenting as a Febrile Seizure. Pediatrics. 2020 Feb;145(2):e20191920. doi: 10.1542/peds.2019-1920.
PubMed 31980544Han JY, Lee IG, Shin S, Park J. Seizure duration may increase thyroid-stimulating hormone levels in children experiencing a seizure. J Int Med Res. 2020 May;48(5):300060519888401. doi: 10.1177/0300060519888401. Epub 2019 Nov 27.
PubMed 31774013
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Febrile Seizures in Children: Association of Thyroxine (T4), Epinephrine, and Norepinephrine Levels With Seizure Characteristics and Hospital Outcomes-A Prospective Controlled Observational Study
- ClinicalTrials.gov ID
- NCT07463222
- Acronym / sponsor ID
- ADUPEDFSTEN
- Conditions
- Febrile Convulsion, Neuroendocrine Stress Response, Fever
- Keywords
- Fever, Febrile seizure, Neuroendocrine response, Pediatric emergency, Child, Thyroxine, Epinephrine, Norepinephrine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Mar 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.
Febrile seizures are the most common seizure type in early childhood and usually occur during febrile illnesses. Although most febrile seizures are benign, the biological stress response during seizures is not fully understood. In particular, changes in thyroid hormones and stress-related hormones released by the sympathetic nervous system may play a role in seizure characteristics and clinical outcomes.
This prospective observational study aims to evaluate the neuroendocrine response in children presenting with febrile seizures by measuring serum thyroxine (T4), epinephrine, and norepinephrine levels. These measurements will be obtained during the acute phase after seizure cessation and compared with levels measured at recovery and with febrile children without seizures.
The study will examine the relationship between neuroendocrine marker levels and seizure characteristics such as seizure duration and recurrence, as well as clinical outcomes including length of hospital stay and need for pediatric intensive care unit admission.
By improving understanding of the hormonal stress response associated with febrile seizures, this study aims to contribute to the knowledge of seizure pathophysiology in childhood and may help identify biological factors associated with more severe clinical courses.
Detailed description
Febrile seizures represent a common pediatric neurological emergency and are triggered by fever-related systemic stress rather than primary epileptic pathology. Acute febrile seizures are accompanied by activation of the hypothalamic-pituitary-thyroid axis and the sympathetic-adrenal system, resulting in measurable changes in circulating thyroid hormones and catecholamines. However, the magnitude and clinical relevance of this neuroendocrine response remain incompletely characterized.
This study is designed as a prospective, observational, case-control investigation conducted in a pediatric emergency department setting. Children aged 6 months to 5 years presenting with febrile seizures will be enrolled as the case group. An age-matched control group will consist of febrile children without seizures. Participants will not be assigned to any intervention, and all clinical management will follow standard care practices.
In the febrile seizure group, blood samples for measurement of serum thyroxine (T4), epinephrine, and norepinephrine will be obtained within 30 minutes after seizure cessation to capture the acute neuroendocrine stress response. Additional samples will be collected prior to hospital discharge to assess recovery-phase hormone levels. In the control group, blood samples will be collected during the febrile episode at the time of clinical evaluation. All laboratory analyses will be performed using validated methods under standardized conditions.
Clinical data collected will include demographic characteristics, fever features, seizure type and duration, recurrence during hospitalization, treatment administered, length of hospital stay, and requirement for pediatric intensive care unit admission. The primary objective is to evaluate associations between acute-phase neuroendocrine marker levels and seizure characteristics, particularly seizure duration and recurrence. Secondary objectives include comparisons between febrile seizure patients and febrile controls, as well as associations between hormone levels and clinical outcomes.
Statistical analyses will include descriptive methods, group comparisons using parametric or nonparametric tests as appropriate, correlation analyses, and multivariable regression models adjusting for relevant confounders such as age, sex, peak temperature, seizure type, and treatment exposure. The study aims to provide mechanistic insight into the neuroendocrine stress response associated with febrile seizures and to explore its potential relationship with disease severity and short-term outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Febrile Seizure Patients | – | –Children aged 6 months to 5 years presenting with febrile seizures who are enrolled prospectively. Blood samples are obtained within 30 minutes after seizure cessation to assess acute neuroendocrine response, including thyroxine (T4), epinephrine, and norepinephrine levels. Additional samples are collected prior to hospital discharge. Clinical data including seizure characteristics, recurrence, length of hospital stay, and need for pediatric intensive care unit admission are recorded. No experimental intervention is administered. |
| Febrile Controls | – | –Age-matched febrile children without seizures enrolled as the control cohort. Blood samples are obtained during the febrile episode to measure thyroxine (T4), epinephrine, and norepinephrine levels. Clinical data related to fever characteristics are collected for comparison with the febrile seizure cohort. No experimental intervention is administered. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes children aged 6 months to 5 years presenting with febrile seizures and an age-matched febrile control group without seizures, enrolled prospectively in a pediatric emergency department. The study evaluates differences in acute neuroendocrine hormone levels (thyroxine [T4], epinephrine, and norepinephrine) and their associations with seizure characteristics and short-term hospital outcomes.
Key inclusion criteria (4 listed)
- Children aged 6 months to 5 years presenting to the pediatric emergency department with fever (documented at presentation or reported by caregiver within the preceding 24 hours).
- Case group: febrile seizure occurring in the context of a febrile illness.
- Control group: febrile illness without seizure, selected to be age-matched to cases (e.g., within ±6 months).
- Written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (7 listed)
- Suspected or confirmed central nervous system infection (e.g., meningitis, encephalitis).
- Prior diagnosis of epilepsy or history of afebrile seizures.
- Seizures attributable to acute metabolic derangements at presentation (e.g., significant hypoglycemia, clinically relevant electrolyte disturbances).
- Known thyroid disease or use of thyroid hormone/antithyroid medications.
- Known adrenal disorders or use of systemic catecholamine infusions at enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in acute neuroendocrine hormone levels between febrile seizure patients and febrile controls
Time frame: Baseline (during the emergency department presentation)
The difference in serum thyroxine (T4), epinephrine, and norepinephrine levels measured during the acute phase between children presenting with febrile seizures and age-matched febrile children without seizures.
3 secondary outcomes
Association between neuroendocrine hormone levels and seizure duration
Time frame: Baseline (during the index febrile seizure event)
Association between neuroendocrine hormone levels and hospital length of stay
Time frame: From hospital admission through discharge (up to 7 days)
Association between neuroendocrine hormone levels and pediatric intensive care unit admission
Time frame: During the index hospitalization (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 9686652Asami T, Sasagawa F, Kyo S, Asami K, Uchiyama M. Incidence of febrile convulsions in children with congenital hypothyroidism. Acta Paediatr. 1998 Jun;87(6):623-6. doi: 10.1080/080352598750014003.
- Background: PubMed 31059921Thebault-Dagher F, Lafontaine MP, Knoth IS, Deguire F, Sheppard E, Cook R, Lagace M, Gravel J, Lupien S, Lippe S. Febrile seizures and increased stress sensitivity in children: How it relates to seizure characteristics. Epilepsy Behav. 2019 Jun;95:154-160. doi: 10.1016/j.yebeh.2019.03.022. Epub 2019 May 3.
- Background: PubMed 31980544Ladd JM, Sabsabi B, von Oettingen JE. Thyroid Storm in a Toddler Presenting as a Febrile Seizure. Pediatrics. 2020 Feb;145(2):e20191920. doi: 10.1542/peds.2019-1920.
- Background: PubMed 31774013Han JY, Lee IG, Shin S, Park J. Seizure duration may increase thyroid-stimulating hormone levels in children experiencing a seizure. J Int Med Res. 2020 May;48(5):300060519888401. doi: 10.1177/0300060519888401. Epub 2019 Nov 27.
- Individual participant dataSharing planned: No
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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.
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 Convulsion and Neuroendocrine Stress Response, run by Aydin Adnan Menderes University 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 11 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aykut Çağlar, MD (+905303337877, aykutcaglar@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in acute neuroendocrine hormone levels between febrile seizure patients and febrile controls (time frame: Baseline (during the emergency department presentation)). 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 NCT07463222, which also lists 4 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 11 Mar 2026.