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

Febrile Seizure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967066
• Other study ID #: Soh-Med-21-07-06
• Status: Completed
• Start date: August 23, 2021
• Est. completion date: October 2, 2022

Study information

• Verified date: October 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Febrile Seizure
• Fever
• Hyperthermia
• Seizures
• Seizures, Febrile

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sohag University Hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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