Neuroendocrine Response in Pediatric Febrile Seizures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-5
SponsorAydin Adnan Menderes University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Febrile Seizure Patients
Group B: Febrile Controls
Trial outcomes
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.
Time frame
Baseline (during the emergency department presentation)Secondary outcomes
1
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.
Time frame
Baseline (during the index febrile seizure event)2
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.
Time frame
From hospital admission through discharge (up to 7 days)3
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.
Time frame
During the index hospitalization (up to 7 days)Sponsors and contacts
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Source ClinicalTrials.gov
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