A Cross-Sectional Study of Serum Levels of Adipocytokines in Children With Febrile Seizures

Completed

• Conditions: Febrile Seizure
• Interventions: Diagnostic Test: Serum Levels of Adipocytokines

• Registration Number: NCT04967066
• Lead Sponsor: Sohag University

Brief Summary

Febrile seizure (FS) is a common neurological condition in children, affecting 2 - 14% of children. FS is defined as seizures occurring in a child aged from six months to five years that is accompanied by a fever (≥38°C) without central nervous system infection. FS is classified into simple febrile seizure (SFS) and complex febrile seizure (CFS). SFS accounts for 70-75% of FS cases and is characterized by being generalized, duration of less than 15 minutes, occurs once in 24 hours, and no previous neurologic problems. We aim to investigate serum levels of adipocytokines, specifically leptin, adiponectin, and IL-6, in children with FS.

Detailed Description

The study will include three groups of children (100 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). Children included in this study will undergo:

* Thorough medical history taking: including age, gender, and seizure details for children with febrile seizures (e.g., type, duration, recurrence).

* Physical examination: including vital signs (particularly temperature) and comprehensive neurological examination).

* Laboratory investigations:

* Routine investigations: complete blood count, C-reactive protein, blood glucose, serum electrolytes (sodium, potassium, calcium, and magnesium), liver and kidney function tests.

* Serum leptin and adiponectin: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin and adiponectin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-19
• Study Start: 2021-08-23
• Primary Completion: 2022-09-23
• Status Verified: 2022-10
• Study Completion: 2022-10-02
• Last Update Submitted: 2022-10-02
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age from 6 months to 6 years.
• Seizures.
• Fever (≥38°C) due to acute infection.
• Presented for routine check-up.

Exclusion Criteria

• Central nervous system infection.
• Epilepsy.
• Previous neurological abnormalities.
• Inborn errors of metabolism.
• Immunological diseases.
• Endocrinal diseases (e.g., diabetes mellitus).
• Obesity.
• Eating disorders.
• Gastrointestinal disorders (e.g., diarrhea).
• Seizures.
• Previous neurological abnormalities
• Any illness in the last month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with febrile convulsions	Serum Levels of Adipocytokines	* Inclusion criteria * Age from 6 months to 6 years. * Seizures. * Fever (≥38°C). * Exclusion criteria * Central nervous system infection. * Epilepsy. * Previous neurological abnormalities. * Inborn errors of metabolism. * Immunological diseases. * Endocrinal diseases (e.g., diabetes mellitus). * Obesity. * Eating disorders. * Gastrointestinal disorders (e.g., diarrhea).
Febrile children without convulsions	Serum Levels of Adipocytokines	* Inclusion criteria * Age from 6 months to 6 years. * Fever (≥38°C) due to acute infection. * Exclusion criteria * Seizures. * Central nervous system infection. * Previous neurological abnormalities. * Inborn errors of metabolism. * Immunological diseases. * Endocrinal diseases (e.g., diabetes mellitus). * Obesity. * Eating disorders. * Gastrointestinal disorders (e.g., diarrhea).
Healthy control children	Serum Levels of Adipocytokines	* Inclusion criteria * Age from 6 months to 6 years. * Presented for routine check-up. * Exclusion criteria * Fever. * Seizures. * Central nervous system infection. * Previous neurological abnormalities. * Inborn errors of metabolism. * Immunological diseases. * Endocrinal diseases (e.g., diabetes mellitus). * Obesity. * Eating disorders. * Gastrointestinal disorders (e.g., diarrhea). * Any illness in the last month.

Primary Outcome Measures

Name	Time	Method
Serum leptin	within 3 hours of seizures	venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.
Serum adiponectin	within 3 hours of seizures	venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum adiponectin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Trial Locations

Locations (1)

Sohag University Hospitals; 🇪🇬 Sohag, Egypt