- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05008458
Value of Von Willebrand Factor and Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
August 14, 2021 updated by: Mahmoud Ali Abdelrady, Sohag University
Febrile seizures are one of the most common clinical diseases in pediatric neurology.
It occurs between 6 months and 6 years of age and occurs in ~2-5% of children.
According to the age, frequency, duration, and type of seizures FS is divided into simple febrile seizures and complex febrile seizures Differentiation between febrile seizures and non-ictal events associated with fever such as shivering or dizziness is challenging.
Therefore, precise diagnosis of FS after paroxysmal episodes associated with fever is often hindered by the lack of an objective biomarker With the widespread application of technologies, such as molecular biology, in medicine, some biomarkers for predicting or diagnosing FS have attracted attention.
Imuekemhe et al in 1989 and 1996 found that lactic acid in the serum and cerebrospinal fluid of children with FS was significantly increased .
Arginin-vasopressin hormone AVP released by the pituitary gland, has been shown to be involved in the thermoregulatory response to fever and convulsions Although AVP is unstable in the peripheral blood and, therefore, unsuited for diagnostic use the C-terminal portion of the AVP precursor copeptin has been recognized as a robust marker of AVP secretion .
Wellman et al. found that the serum copeptin and Von Willebrand factor of children with FS were significantly higher than those of the control group .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
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 Contact
- Name: Mahmoud A abd elrady, resident
- Phone Number: 01276923636
- Email: mahmoud011175@med.sohag.edu.eg
Study Contact Backup
- Name: abd el rahim A Sadek, professor
Study Locations
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Sohag, Egypt
- Sohag University Hospital
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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
Ages Eligible for Study
6 months to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study will include three groups of children (30 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3).
at Pediatric neurology outpatient clinic and Pediatric Department at Sohag University Hospital.
Description
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).
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children with febrile seizures
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biomarkers increase in children with febrile seizures
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febrile children without seizures
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biomarkers increase in children with febrile seizures
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healthy control children
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biomarkers increase in children with febrile seizures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Value of von willebrand factor and copeptin assay in children with febrile seizures at Sohag University Hospital
Time Frame: one year
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Serum copeptin and Von Willebrand factor (VWF) venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. .
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.
- Patel N, Ram D, Swiderska N, Mewasingh LD, Newton RW, Offringa M. Febrile seizures. BMJ. 2015 Aug 18;351:h4240. doi: 10.1136/bmj.h4240. No abstract available.
- Pechmann A, Wellmann S, Stoecklin B, Kruger M, Zieger B. Increased von Willebrand factor parameters in children with febrile seizures. PLoS One. 2019 Jan 3;14(1):e0210004. doi: 10.1371/journal.pone.0210004. eCollection 2019.
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 (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
May 15, 2022
Study Registration Dates
First Submitted
July 28, 2021
First Submitted That Met QC Criteria
August 14, 2021
First Posted (Actual)
August 17, 2021
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 14, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-med-21-07-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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