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

NCT ID: NCT04967066

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-23

Study Completion Date

2022-10-02

Brief Summary

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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

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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.

Conditions

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Febrile Seizure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Serum Levels of Adipocytokines

Intervention Type 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

* 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).

Serum Levels of Adipocytokines

Intervention Type 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.

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.

Serum Levels of Adipocytokines

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Hagar Abdelhamid Mohamed

Resident of Pediatrics, Sohag University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelrahim A. Sadek, Professor

Role: STUDY_DIRECTOR

Sohag University

Abdelhady R. Abdel-Gawad, Lecturer

Role: STUDY_CHAIR

Sohag University

Elsayed M. Abdelkreem, Lecturer

Role: STUDY_CHAIR

Sohag University

Locations

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Sohag University Hospitals

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-21-07-06

Identifier Type: -

Identifier Source: org_study_id

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