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

Serum Levels of Adipocytokines in Children With Febrile Seizures: A Cross-Sectional Study at Sohag University Hospital

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.

Study Overview

• Status: Completed
• Conditions: Febrile Seizure
• Intervention / Treatment: Diagnostic test: Serum Levels of Adipocytokines

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chi-square test will be used in comparing qualitative data between two groups, and Fisher exact test will be used instead of the Chi-square test when the expected count in any cell is less than 5. Student's T-test will be used in the comparison between two groups with quantitative data and parametric distribution, and Mann-Whitney test will be used in the comparison between two groups with quantitative data and non-parametric distribution. One-way analysis of variance (ANOVA) and Kruskal-Wallis tests will be used to compare more than two independent groups for quantitative data with parametric and non-parametric distribution, respectively. Pearson's and Spearman's correlation will be used to test the correlation analysis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
children with febrile convulsions; 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).	Diagnostic test: Serum Levels of Adipocytokines; 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. The 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.
Febrile children without convulsions; 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).	Diagnostic test: Serum Levels of Adipocytokines; 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. The 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.
Healthy control children; 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.	Diagnostic test: Serum Levels of Adipocytokines; 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. The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum leptin	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.	within 3 hours of seizures
Serum adiponectin	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.	within 3 hours of seizures

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Director: Abdelrahim A. Sadek, Professor, Sohag University; Study Chair: Abdelhady R. Abdel-Gawad, Lecturer, Sohag University; Study Chair: Elsayed M. Abdelkreem, Lecturer, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): October 2, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Seizures; Hyperthermia; Fever; Seizures, Febrile
• Other Study ID Numbers: Soh-Med-21-07-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No