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

October 2, 2022 updated by: Hagar Abdelhamid Mohamed, Sohag University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
within 3 hours of seizures
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.
within 3 hours of seizures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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