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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05215366
Collaborator
(none)
90
1
7.2
12.5

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: copeptin biomarker in children with febrile seizures

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
Actual Study Start Date :
Jan 7, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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. .

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahmoud Ali Abdelrady, resident doctor at pediateric department sohag university hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05215366
Other Study ID Numbers:
  • Soh-Med-22-01-07
First Posted:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022