Febrile SeizureNCT04967066
A Cross-Sectional Study of Serum Levels of Adipocytokines in Children With Febrile Seizures
An observational study of Febrile Seizure, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Febrile Seizure
- What is being tested?
- Serum Levels of Adipocytokines
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2021to 2 Oct 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Age from 6 months to 6 years.
- Seizures.
- Fever (≥38°C) due to acute infection.
- Presented for routine check-up.
Who cannot join
- Central nervous system infection.
- Epilepsy.
- Previous neurological abnormalities.
- Inborn errors of metabolism.
- Immunological diseases.
- Endocrinal diseases (e.g., diabetes mellitus).
Show all 12Show fewer
- Obesity.
- Eating disorders.
- Gastrointestinal disorders (e.g., diarrhea).
- Seizures.
- Previous neurological abnormalities
- Any illness in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Febrile Seizure
- Being tested
- Serum Levels of Adipocytokines
- Medical subject headings
- Seizures, Febrile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Levels of AdipocytokinesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Diagnostic Test: Serum Levels of Adipocytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 3 hours of seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start23 Aug 2021
- Primary completion23 Sep 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile SeizureStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Abdelhamid Mohamed, Sohag University
- Investigators
- Abdelrahim A. Sadek, Professor, Study director, Sohag UniversityAbdelhady R. Abdel-Gawad, Lecturer, Study chair, Sohag UniversityElsayed M. Abdelkreem, Lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967066
- Sponsor's protocol ID
- Soh-Med-21-07-06
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Adipocytokines in Children With Febrile Seizures: A Cross-Sectional Study at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04967066
- Acronym / sponsor ID
- Soh-Med-21-07-06
- Conditions
- Febrile Seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children with febrile convulsions | – | Diagnostic Test: Serum Levels of Adipocytokines* 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). |
| Febrile children without convulsions | – | Diagnostic Test: Serum Levels of Adipocytokines* 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). |
| Healthy control children | – | Diagnostic Test: Serum Levels of Adipocytokines* 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. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Age from 6 months to 6 years.
- Seizures.
- Fever (≥38°C) due to acute infection.
- Presented for routine check-up.
Key exclusion criteria (12 listed)
- Central nervous system infection.
- Epilepsy.
- Previous neurological abnormalities.
- Inborn errors of metabolism.
- Immunological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Levels of AdipocytokinesSerum 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. | Diagnostic test | Febrile children without convulsions, Healthy control children, children with febrile convulsions |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelrahim A. Sadek, Professor study director
Sohag University
Abdelhady R. Abdel-Gawad, Lecturer study chair
Sohag University
Elsayed M. Abdelkreem, Lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Seizure, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum leptin (time frame: within 3 hours of seizures). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.