NCT03481764

Brief Summary

Febrile seizures(FS) are the most common neurological disorder in chilhood and are a great stress for parents due to their dramatic clinical appearance. Using HRC-test(test for determination of homozygously recessive characteristics in humans) we analyzed presence, distribution, and individual combination of 20 selected genetically controlled morpho-physiological traits among FS patients and control to determine a possible deviation in the homozygosity level and genetic loads in the group of affected children and whether there is a predisposition to the occurrence of FS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

March 22, 2018

Last Update Submit

April 24, 2020

Conditions

Keywords

febrile seizureHRC-testgenetic variationepilepsy

Outcome Measures

Primary Outcomes (1)

  • To establish the degree of genetic homozygosity and variability in subjects with Febrile Seizure and control group

    Using HRC-test (test for determination of homozygously recessive characteristics in humans) we will analyzed presence, distribution, and individual combination of 20 selected genetically controlled morpho-physiological traits among FS patients and control to determine a possible deviation in the homozygosity level and genetic loads in the group of affected children and whether there is a predisposition to the occurrence of FS.

    2 years

Secondary Outcomes (1)

  • Establish a correlation between the degree of genetic homozygosity and variability between subjects with SFS and CFS, also WFS and EFS

    2 years

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 5-14 years

Genetic: HRC-test

CN: Control group

The control group was made of healthy children older than 5 years of age, which have never had any neurological disorders in their anamnesis and who were patients in preschool or school dispensaries in the city of Belgrade

Genetic: HRC-test

SFS : group of individuals with simple FS

Simplex febrile seizures (SFS) last shorter than 15 minutes and their type is tonic-clonic. Also, they did not show signs of recidivism during the first 24 hours and were diagnosed at the patients aged from 6th months to 5th year

Genetic: HRC-test

CFS : group of individuals with complex FS

Complex febrile seizures (CFS) were diagnosed at those patients that had focal seizure or epileptic status or seizure having the body temperature lower than 38 degree, which occurred outside of the typical age group and finally which repeated in the first 24 hours again

Genetic: HRC-test

WFS: group of individuals with FS and without epilepsia

group of children with Febrile Seizure and not developed epilepsia

Genetic: HRC-test

EFS: group of individuals with epilepsia and Febrile Seizures

Group of children with Febrile Seizures, who have developed Epilepsy

Genetic: HRC-test

Interventions

HRC-testGENETIC

Using HRC-test we analyze 20 selected genetically controlled morphophysiological traits among FS children and control.Homozygous-recessive traits in the region of human head are: attached ear lobe,continuous frontal hair line,blue eyes straight hair,soft hair and blond hair,double hair whorl,hair whorl orientation-opposite from clock-wise,as well as an inability to roll,fold and curve the tongue,a guttural "r and Daltonism.HRC trait expressed in human arms and legs, such as distal or proximal hyper-extensibility of the thumb,index finger shorter than the ring finger,left-handedness, hand clasping pattern.In order to achieve high level of objectivity during the process of data gathering, the same person conducting all testing.Inside the group of charcteristics which show high level of variability,only the extreme phenotypes were considered recessive.For the purpose of testing the color blindness in examinees,the Pseudoisochromatic plates test was used.

CFS : group of individuals with complex FSCN: Control groupEFS: group of individuals with epilepsia and Febrile SeizuresFS: Febrile SeizuresSFS : group of individuals with simple FSWFS: group of individuals with FS and without epilepsia

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The Febrile Seizure affected children as well as the individuals from the control group were members of the same population (Serbian)

You may qualify if:

  • Our research has involved patient with diagnosed Febrile Seizure which were hospitalized or recieved ambulatory treatment in University Children´s Hospital in Belgrade.

You may not qualify if:

  • Patients with evidence of intracranial infections
  • Patients with incomplited medical documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanja Dimitrijevic

Belgrade, 11000, Serbia

Location

Related Publications (6)

  • Nikolic D, Petronic I, Cvjeticanin S, Brdar R, Cirovic D, Bizic M, Konstantinovic L, Matanovic D. Gender and morphogenetic variability of patients with spina bifida occulta and spina bifida aperta: prospective population-genetic study. Hippokratia. 2012 Jan;16(1):35-9.

    PMID: 23930055BACKGROUND
  • Cvjeticanin S, Marinkovic D. Morphogenetic variability during selection of elite water polo players. J Sports Sci. 2009 Jul;27(9):941-7. doi: 10.1080/02640410902960494.

    PMID: 19629843BACKGROUND
  • Marinkovic D, Cvjeticanin S. Population-genetic study of Balkan endemic nephropathy in Serbia. Genetika. 2007 Aug;43(8):1134-8.

    PMID: 17958315BACKGROUND
  • Cvjeticanin S, Marinkovic D. Genetic variability in the group of patients with congenital hip dislocation. Genetika. 2005 Aug;41(8):1142-6.

    PMID: 16161637BACKGROUND
  • Khair AM, Elmagrabi D. Febrile Seizures and Febrile Seizure Syndromes: An Updated Overview of Old and Current Knowledge. Neurol Res Int. 2015;2015:849341. doi: 10.1155/2015/849341. Epub 2015 Nov 30.

    PMID: 26697219BACKGROUND
  • Dimitrijevic S, Cvjeticanin S, Pusica A, Jekic B, Filipovic T, Nikolic D. Anthropogenetic Variability in the Group of Individuals with Febrile Seizures: Population-Genetic Study. Biomed Res Int. 2018 Jul 5;2018:7845904. doi: 10.1155/2018/7845904. eCollection 2018.

    PMID: 30069480BACKGROUND

MeSH Terms

Conditions

Seizures, FebrileEpilepsy

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 29, 2018

Study Start

September 1, 2015

Primary Completion

April 1, 2018

Study Completion

September 1, 2019

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations