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

NCT04967066 | Completed

• 1 other identifier: Soh-Med-21-07-06
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Seizure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

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

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

Interventions

Serum Levels of Adipocytokines DIAGNOSTIC_TEST

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; Healthy control children; children with febrile convulsions

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, 82524, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Seizures, Febrile

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdelrahim A. Sadek, Professor

  Sohag University

  STUDY DIRECTOR

• Abdelhady R. Abdel-Gawad, Lecturer

  Sohag University

  STUDY CHAIR

• Elsayed M. Abdelkreem, Lecturer

  Sohag University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Pediatrics, Sohag University Hospital

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 19, 2021
• Study Start: August 23, 2021
• Primary Completion: September 23, 2022
• Study Completion: October 2, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Locations

EG (1)