NCT05215366

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

January 18, 2022

Last Update Submit

January 18, 2022

Conditions

Febrile Seizure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

children with febrile seizures

Diagnostic Test: copeptin biomarker in children with febrile seizures

febrile children without seizures

Diagnostic Test: copeptin biomarker in children with febrile seizures

healthy control children

Diagnostic Test: copeptin biomarker in children with febrile seizures

Interventions

copeptin biomarker in children with febrile seizuresDIAGNOSTIC_TEST

biomarkers increase in children with febrile seizures

children with febrile seizuresfebrile children without seizureshealthy control children

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

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: 26286537BACKGROUND

  • 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: 30038660BACKGROUND

  • 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: 30605489BACKGROUND

MeSH Terms

Conditions

Seizures, Febrile

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mahmoud A abd elrady, resident

CONTACT

01276923636mahmoud011175@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

January 18, 2022

First Posted

January 31, 2022

Study Start

January 7, 2022

Primary Completion

August 1, 2022

Study Completion

August 15, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)