Value of Von Willebrand Factor and Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital

NCT05008458 | Unknown

• 1 other identifier: soh-med-21-07-16
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Febrile Seizure

Outcome Measures

Primary Outcomes (1)

• Value of von willebrand factor and copeptin assay in children with febrile seizures at Sohag University Hospital

  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. .

  one year

Study Arms (3)

children with febrile seizures

Diagnostic Test: von willebrand factor and copeptin

febrile children without seizures

Diagnostic Test: von willebrand factor and copeptin

healthy control children

Diagnostic Test: von willebrand factor and copeptin

Interventions

von willebrand factor and copeptin DIAGNOSTIC_TEST

biomarkers increase in children with febrile seizures

children with febrile seizures; febrile children without seizures; healthy control children

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age from 6 months to 6 years.
• Seizures.
• Fever (≥38°C).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

• 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.

  PMID: 26286537 BACKGROUND

• Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.

  PMID: 30038660 BACKGROUND

• 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.

  PMID: 30605489 BACKGROUND

MeSH Terms

Conditions

Seizures, Febrile

Condition Hierarchy (Ancestors)

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

Central Study Contacts

mahmoud a abd elrady, resident

CONTACT

01276923636; mahmoud011175@med.sohag.edu.eg

abd el rahim A Sadek, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at pediateric department sohag university hospital

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 17, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 15, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)