Neuroendocrine Response in Pediatric Febrile Seizures

NCT07463222 | Not Yet Recruiting

• 1 other identifier: ADUPEDFSTEN
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Febrile Convulsion; Neuroendocrine Stress Response; Fever

Keywords

Fever; Febrile seizure; Neuroendocrine response; Pediatric emergency; Child; Thyroxine; Epinephrine; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (during the emergency department presentation)

Secondary Outcomes (3)

• Association between neuroendocrine hormone levels and seizure duration

  Baseline (during the index febrile seizure event)

• Association between neuroendocrine hormone levels and hospital length of stay

  From hospital admission through discharge (up to 7 days)

• Association between neuroendocrine hormone levels and pediatric intensive care unit admission

  During the index hospitalization (up to 7 days)

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University Hospital

Aydin, Aydın, 09010, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 9686652 BACKGROUND

• Thebault-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.

  PMID: 31059921 BACKGROUND

• Ladd 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.

  PMID: 31980544 BACKGROUND

• Han 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.

  PMID: 31774013 BACKGROUND

MeSH Terms

Conditions

Seizures, Febrile; Fever

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Central Study Contacts

Aykut Çağlar, MD

CONTACT

+905303337877; aykutcaglar@adu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)