Febrile SeizureNCT03481764
Anthropogenetic Variability in the Group of Individuals With Febrile Seizures
An observational study of Febrile Seizure, run by Institut za Rehabilitaciju Sokobanjska Beograd at 1 site in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Febrile Seizure
- What is being tested?
- HRC-test
- How many people
- 150 participants
- Where
- 1 siteSerbia
- Study dates
- Sep 2015to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The Febrile Seizure affected children as well as the individuals from the control group were members of the same population (Serbian)
Who may be able to join
- Our research has involved patient with diagnosed Febrile Seizure which were hospitalized or recieved ambulatory treatment in University Children´s Hospital in Belgrade.
Who cannot join
- Patients with evidence of intracranial infections
- Patients with incomplited medical documentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anthropogenetic Variability in the Group of Individuals With Febrile Seizures - Population Genetic Study
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.
Read the detailed description
Febrile seizures(FS) are one of the most common neurological disorders in children and infants. It is estimated that 2-5% of children younger than 5 years of age experience at least one epileptic seizure during the period of febrile seizure.
FS, as defined by the American Academy of Pediatrics (AAP), are " seizure occurring in febrile children between the ages of 6 and 60 months who do not have an intracranial infection, metabolic disturbance, or history of afebrile seizures ".
The diagnosis of FS is based on physical examination and anamnesis taken from the gardian, aiming primarily to detect the real cause that led to a FS.
The etiology of FS is complex and it is still the subject of numerous studies and research done in the field. However, there is strong evidence showing that heterogeneous genetic predisposition interacting with various risk factors can lead to a FS.
There are several risk factors mentioned in literature which can cause the first FS. One of the most important is positive family history of FS (especially among the closest relatives) . Other possible factors include: high body temperature (the higher level of body temperature increases the risk of a seizure occurrence), preexisting neurodevelopment delay , neonatal care longer that 28 days.
The development of epilepsy after FS moves around 3%, after simple febrile seizure (SFS) the risk is around 2% whereas after complex febrile seizure (CFS) it is about 2 to 3%. Around 13% of epilepsy patients have experienced FS once. Prolonged FS can lead to mesial temporal sclerosis and to temporal lobe epilepsy, but the level of risk is still uncertain.
The research shows that abnormal neurological development before the FS, the occurrences of a febrile seizures among relatives, as well as the CFS, represent risk factors for emergence of epilepsy after the FS.
Since FS are genetically controlled, it is presumed that increased homozygosity and decreased variability in patients can be in correlation with the expression of FS.
The determination of the presence of homozygous-recessive characteristics (HRC) in individuals with FS provides an insight whether the prevalence of homozygous or heterozygous loci on different chromosomes exists. The number of homozygous recessive traits represent one type of indicator of the homologous chromosomal homozygosity, which can vary significantly both at the individual, as well as at the group level.
- Conditions
- Febrile Seizure
- Being tested
- HRC-test
- Keywords
- febrile seizure, HRC-test, genetic variation, epilepsy
- Medical subject headings
- Seizures, Febrile, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Genetic: HRC-test | |
| WFS: group of individuals with FS and without epilepsia | group of children with Febrile Seizure and not developed epilepsia Receives: Genetic: HRC-test | |
| EFS: group of individuals with epilepsia and Febrile Seizures | Group of children with Febrile Seizures, who have developed Epilepsy Receives: Genetic: HRC-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The results of HRC test shows a degree of genetic homozygosity as well as the level of possible genetic loads what may indicate to the presence of genetic problems which further affect the capacity of normal development, with the possibility for more extreme cases to develop specific properties including increased or desreased resistance to certain types of illness
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startSep 2015
- Primary completionApr 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Febrile SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska Beograd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Filipovic, Institut za Rehabilitaciju Sokobanjska Beograd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481764
- Sponsor's protocol ID
- Sbcprn
- Status last verified
- Apr 2020
- First submitted
- 22 Mar 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 23930055Cvjeticanin 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.
PubMed 19629843Marinkovic D, Cvjeticanin S. Population-genetic study of Balkan endemic nephropathy in Serbia. Genetika. 2007 Aug;43(8):1134-8.
PubMed 17958315Cvjeticanin S, Marinkovic D. Genetic variability in the group of patients with congenital hip dislocation. Genetika. 2005 Aug;41(8):1142-6.
PubMed 16161637Khair 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.
PubMed 26697219Dimitrijevic 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.
PubMed 30069480
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropogenetic Variability in the Group of Individuals With Febrile Seizures - Population Genetic Study
- ClinicalTrials.gov ID
- NCT03481764
- Acronym / sponsor ID
- Sbcprn
- Conditions
- Febrile Seizure
- Keywords
- febrile seizure, HRC-test, genetic variation, epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut za Rehabilitaciju Sokobanjska BeogradUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Febrile seizures(FS) are one of the most common neurological disorders in children and infants. It is estimated that 2-5% of children younger than 5 years of age experience at least one epileptic seizure during the period of febrile seizure.
FS, as defined by the American Academy of Pediatrics (AAP), are " seizure occurring in febrile children between the ages of 6 and 60 months who do not have an intracranial infection, metabolic disturbance, or history of afebrile seizures ".
The diagnosis of FS is based on physical examination and anamnesis taken from the gardian, aiming primarily to detect the real cause that led to a FS.
The etiology of FS is complex and it is still the subject of numerous studies and research done in the field. However, there is strong evidence showing that heterogeneous genetic predisposition interacting with various risk factors can lead to a FS.
There are several risk factors mentioned in literature which can cause the first FS. One of the most important is positive family history of FS (especially among the closest relatives) . Other possible factors include: high body temperature (the higher level of body temperature increases the risk of a seizure occurrence), preexisting neurodevelopment delay , neonatal care longer that 28 days.
The development of epilepsy after FS moves around 3%, after simple febrile seizure (SFS) the risk is around 2% whereas after complex febrile seizure (CFS) it is about 2 to 3%. Around 13% of epilepsy patients have experienced FS once. Prolonged FS can lead to mesial temporal sclerosis and to temporal lobe epilepsy, but the level of risk is still uncertain.
The research shows that abnormal neurological development before the FS, the occurrences of a febrile seizures among relatives, as well as the CFS, represent risk factors for emergence of epilepsy after the FS.
Since FS are genetically controlled, it is presumed that increased homozygosity and decreased variability in patients can be in correlation with the expression of FS.
The determination of the presence of homozygous-recessive characteristics (HRC) in individuals with FS provides an insight whether the prevalence of homozygous or heterozygous loci on different chromosomes exists. The number of homozygous recessive traits represent one type of indicator of the homologous chromosomal homozygosity, which can vary significantly both at the individual, as well as at the group level.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FS: Febrile Seizures | – | Genetic: HRC-testInvolved patient with diagnosed Febrile Seizures which were hospitalized or recieved ambulatory treatment in University Children´s Hospital in Belgrade. Ages 5-14 years |
| CN: Control group | – | Genetic: HRC-testThe 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 |
| SFS : group of individuals with simple FS | – | Genetic: HRC-testSimplex 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 |
| CFS : group of individuals with complex FS | – | Genetic: HRC-testComplex 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 |
| WFS: group of individuals with FS and without epilepsia | – | Genetic: HRC-testgroup of children with Febrile Seizure and not developed epilepsia |
| EFS: group of individuals with epilepsia and Febrile Seizures | – | Genetic: HRC-testGroup of children with Febrile Seizures, who have developed Epilepsy |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The Febrile Seizure affected children as well as the individuals from the control group were members of the same population (Serbian)
Key inclusion criteria (1 listed)
- Our research has involved patient with diagnosed Febrile Seizure which were hospitalized or recieved ambulatory treatment in University Children´s Hospital in Belgrade.
Key exclusion criteria (2 listed)
- Patients with evidence of intracranial infections
- Patients with incomplited medical documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRC-testUsing 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. | Genetic | CFS : group of individuals with complex FS, CN: Control group, EFS: group of individuals with epilepsia and Febrile Seizures, FS: Febrile Seizures, SFS : group of individuals with simple FS, WFS: group of individuals with FS and without epilepsia |
Primary outcome
To establish the degree of genetic homozygosity and variability in subjects with Febrile Seizure and control group
Time frame: 2 years
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.
1 secondary outcome
Establish a correlation between the degree of genetic homozygosity and variability between subjects with SFS and CFS, also WFS and EFS
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 23930055Nikolic 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.
- Background: PubMed 19629843Cvjeticanin 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.
- Background: PubMed 17958315Marinkovic D, Cvjeticanin S. Population-genetic study of Balkan endemic nephropathy in Serbia. Genetika. 2007 Aug;43(8):1134-8.
- Background: PubMed 16161637Cvjeticanin S, Marinkovic D. Genetic variability in the group of patients with congenital hip dislocation. Genetika. 2005 Aug;41(8):1142-6.
- Background: PubMed 26697219Khair 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.
- Background: PubMed 30069480Dimitrijevic 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Seizure, run by Institut za Rehabilitaciju Sokobanjska Beograd at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the degree of genetic homozygosity and variability in subjects with Febrile Seizure and control group (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481764, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.