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

• Conditions: Febrile Seizure
• Interventions: Diagnostic Test: copeptin biomarker in children with febrile seizures

• Registration Number: NCT05215366
• Lead Sponsor: Sohag University

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-07
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Last Update Submitted: 2022-01-18
• Study First Posted: 2022-01-31
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
febrile children without seizures	copeptin biomarker in children with febrile seizures	-
healthy control children	copeptin biomarker in children with febrile seizures	-
children with febrile seizures	copeptin biomarker in children with febrile seizures	-

Primary Outcome Measures

Name	Time	Method
Value of copeptin assay in children with febrile seizures at Sohag University Hospital	8 months	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. .

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt