Brief Summary

Febrile seizures (FS) are the most common neurological disorder in chilhood. The etiology of FN is still the subject of numerous studies and it is known that it can depend on genetic predisposition.

Trial Health

100

On Track

Trial Health Score

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

Enrollment

121

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Mar 2015

Longer than P75 for all trials

Status

completed

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

6.3 years study duration

Study Start

First participant enrolled

March 31, 2015

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed

12 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed

Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

4.1 years

First QC Date

April 24, 2020

Last Update Submit

October 10, 2021

Conditions

Febrile Seizure

Keywords

gene polymorphismsfebrile seizureKCC2 geneTRPV1 gene

Outcome Measures

Primary Outcomes (2)

Detection of the polymorphism in the TRPV1 gene polymorphisms
The detection of the polymorphism in the TRPV1 gene will be done by the PCR Real time method: During PCR ampification, in addition to primers, an allele of specific oligonucleotide probes is used, which at the 5 'end is labeled with specific fluorescent dye (Reporter dye, eg VIC and FAM), while at the 3' position there is a quencher, which is the role of blocking fluorescence emissions.The fluorescence intensity increases during each cycle and allows us to monitor dynamic reactions in real time.After the final PCR reaction, increasing the fluorescence of the dyes is displayed on the heterozygosity of the test allele. Fluorescence coupling of only one color indicates a homozygous state.VIC dye corresponds to allele C, and FAM dye to allele G.
2 weeks
Detection of the polymorphism in the KCC2 gene polymorphisms
The detection of the polymorphism in the KCC2 gene will be done by the PCR Real time method: During PCR ampification, in addition to primers, an allele of specific oligonucleotide probes is used, which at the 5 'end is labeled with specific fluorescent dye (Reporter dye, eg VIC and FAM), while at the 3' position there is a quencher, which is the role of blocking fluorescence emissions.The fluorescence intensity increases during each cycle and allows us to monitor dynamic reactions in real time.After the final PCR reaction, increasing the fluorescence of the dyes is displayed on the heterozygosity of the test allele. Fluorescence coupling of only one color indicates a homozygous state. VIC dye corresponds to allele C, and FAM dye to allele T.
2 weeks

Study Arms (6)

FS: Febrile Seizures

Involved patient with diagnosed Febrile Seizures which were hospitalized or recieved ambulatory treatment in University Children´s Hospital in Belgrade. Ages 1-14 years