Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital

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: Recruiting
• Conditions: Febrile Seizure
• Intervention / Treatment: Diagnostic test: copeptin biomarker in children with febrile seizures

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• 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

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
children with febrile seizures	Diagnostic test: copeptin biomarker in children with febrile seizures; biomarkers increase in children with febrile seizures
febrile children without seizures	Diagnostic test: copeptin biomarker in children with febrile seizures; biomarkers increase in children with febrile seizures
healthy control children	Diagnostic test: copeptin biomarker in children with febrile seizures; biomarkers increase in children with febrile seizures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of copeptin assay in children with febrile seizures at Sohag University Hospital	Serum copeptin venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. .	8 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Seizures; Hyperthermia; Fever; Seizures, Febrile; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Arginine Vasopressin
• Other Study ID Numbers: Soh-Med-22-01-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No