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

Febrile Seizure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215366
• Other study ID #: Soh-Med-22-01-07
• Status: Recruiting
• Start date: January 7, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: January 2022
• Source: Sohag University
• Contact: Mahmoud A abd elrady, resident
• Phone: 01276923636
• Email: mahmoud011175[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 15, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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).

Related Conditions & MeSH terms

• Febrile Seizure
• Fever
• Hyperthermia
• Seizures
• Seizures, Febrile

Intervention

Diagnostic Test:
• copeptin biomarker in children with febrile seizures
biomarkers increase in children with febrile seizures

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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

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. Review. — View Citation

Pechmann A, Wellmann S, Stoecklin B, Krüger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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