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NCT Number: NCT04967066

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

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.

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Key information

Conditions

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

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University Hospitals

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Serum leptin

    Time frame: 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.

  2. Serum adiponectin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2021
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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