Convulsive SeizuresNCT03374384
The Pattern of Pediatric Seizures at Al-Arish Central Hospital - North Sinai
An observational study of Convulsive Seizures, run by Ehsan M saied.
Trial summary
This study will be carried to: 1. Describe the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies . 2. Provide the basic descriptive information that is necessary for planning future studies. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Convulsive Seizures
- What is being tested?
- No drug intervention
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 24 Aug 2020
- How long will I take part?
- 1 Year
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Area of study: Pediatric department at Al-Arish central hospital in North Sinai. Descriptive cross sectional hospital based study. Data will be collected from patient using semi structured questionnaire through interview with patient care giver.
Who may be able to join
- Patients from 2 months upto 18 years of age with seizures admitted to Al-Arish central Hospital .
Who cannot join
- No exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Pediatric Seizures at Al-Arish Central Hospital - North Sinai
This study will be carried to:
- Describe the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies .
- Provide the basic descriptive information that is necessary for planning future studies.
Read the detailed description
A seizure or convulsion is a paroxysmal, time-limited change in motor activity and/or behavior that results from abnormal electrical activity in the brain .
The International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE) have come to consensus definitions for the terms epileptic seizure and epilepsy, An epileptic seizure is a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain but epilepsy is a disorder of the brain characterized by an enduring predisposition to generate epileptic seizures and by the neurobiologic, cognitive, psychological, and social consequences of this condition.
Approximately 4-10% of children experience at least one seizure (febrile or a febrile) in the 1st 16 yr of life, the cumulative lifetime incidence of epilepsy is 3%, and more than half of the cases start in childhood.
Seizure disorder is a general term that is usually used to include any of several disorders, including epilepsy, febrile seizures, and possibly single seizures and symptomatic seizures secondary to metabolic, infectious, or other etiologies (e.g., hypocalcaemia,meningitis).
In the International League Against Epilepsy (ILAE) classification of etiology of epilepsy, idiopathic epilepsy which occur without organic cause, and symptomatic epilepsy that associated with underlying brain disorder that may or may not be genetic .
The definition of epilepsy requires the occurrence of 2 or more unprovoked seizures occur in a time frame of longer than 24 hr .
There are 2 main types of seizures: generalized and focal, focal seizures are those arising within networks of a single cerebral hemisphere and may remain localized or subsequently become more widely distributed.
Generalized seizures rapidly affect both hemispheres as well as both sides of the body even when caused by a "focal" lesion.
Focal (formerly known as partial) seizures are subdivided into simple partial seizures which is refers to focal seizures with no alteration in consciousness and complex partial seizures associated with altered awareness of the surroundings.
Generalized seizures are further subdivided to tonic (sustained contraction), clonic (rhythmic contractions), myoclonic (rapid shock-like contractions, usually<50 msec in duration, that may be isolated or may repeat but usually are not rhythmic), atonic, or astatic (cause avery momentary loss of tone with sudden fall ) Absence seizures (generalized seizures consisting of staring, unresponsiveness, and eye flutter lasting usually for few seconds).
Seizures triggered by fever, defined as febrile seizures, have been for decades a major issue for children in developed countries Epidemiologic studies have led to the division of febrile seizures into 3 groups, as follows:
- Simple febrile seizures
- Complex febrile seizures
- Symptomatic febrile seizures In Simple febrile seizure is single generalized seizure and lasts less than 15 minutes, The child is otherwise neurologically healthy and without neurologic abnormality by examination or by developmental history and not caused by meningitis, encephalitis, or any other illness affecting the brain .
Complex febrile seizure: This seizure is either focal or prolonged (ie, >15 min), or multiple seizures occur in close succession.
Symptomatic febrile seizure: The child has a preexisting neurologic abnormality or acute illness.
Although the outlook for most children with symptomatic seizures or those associated with epilepsy is generally good, seizures may signal a potentially serious underlying systemic or central nervous system (CNS) disorder that requires thorough investigation and management.
Children may have behaviors that are easily mistaken for epileptic Seizures but are not , these include breath-holding spells ,bed wetting ,night terrors ,tics.
Gastroesophageal reflux may cause arching of the back and twisting of the head to the side in infants, which may be mistaken for tonic-clonic seizures, misdiagnosis is frequent (occurring in about 5 to 30% of cases) .
Descriptive epidemiology of pediatric seizures is important for:
First, knowledge of health care utilization is essential for planning and management.
This study will be carried to:
- Describe the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies .
- Provide the basic descriptive information that is necessary for planning future studies.
- Conditions
- Convulsive Seizures
- Being tested
- No drug intervention
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drug interventionOther
This study will be performed in Al-Arish Central Hospital and will include all patients from 2 months up to 18 years of age with seizures admitted to Al-Arish Central Hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies .
Descriptive cross sectional study Data will be collected from patient using semi structured questionnaire through interview with patient care giver.
Data will be entered, cleaned and analyzed using statistical software program (SPSS version 20).
Descriptive statistics will be presented in the form of percentages for qualitative variables and mean and SD for quantitative data.
Qualitative data will be compared using chi-square test, and quantitative data will be compared using Student's t test, other tests will be used as appropriate .
P-value will be considered significant if less than0.05 for all statistical tests .
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Dec 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion24 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Convulsive SeizuresStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ehsan M saied
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ehsan M saied, Assiut University
- Investigators
- Ehsan mr Saeid, RD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374384
- Sponsor's protocol ID
- 17100278
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freeman JM, Tibbles J, Camfield C, Camfield P. Benign epilepsy of childhood: a speculation and its ramifications. Pediatrics. 1987 Jun;79(6):864-8.
PubMed 3588141Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, Cross JH, van Emde Boas W, Engel J, French J, Glauser TA, Mathern GW, Moshe SL, Nordli D, Plouin P, Scheffer IE. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. doi: 10.1111/j.1528-1167.2010.02522.x. Epub 2010 Feb 26.
PubMed 20196795Dalbem JS, Siqueira HH, Espinosa MM, Alvarenga RP. Febrile seizures: a population-based study. J Pediatr (Rio J). 2015 Nov-Dec;91(6):529-34. doi: 10.1016/j.jped.2015.01.005. Epub 2015 May 26.
PubMed 26022778Verity CM, Golding J. Risk of epilepsy after febrile convulsions: a national cohort study. BMJ. 1991 Nov 30;303(6814):1373-6. doi: 10.1136/bmj.303.6814.1373.
PubMed 1760604Richards CF, Lowe RA. Researching racial and ethnic disparities in emergency medicine. Acad Emerg Med. 2003 Nov;10(11):1169-75. doi: 10.1111/j.1553-2712.2003.tb00599.x.
PubMed 14597491
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Pediatric Seizures at Al-Arish Central Hospital - North Sinai
- ClinicalTrials.gov ID
- NCT03374384
- Acronym / sponsor ID
- 17100278
- Conditions
- Convulsive Seizures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ehsan M saiedUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 24 Aug 2020 (estimated)
- First posted
- 15 Dec 2017 (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.
This study will be carried to:
- Describe the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies .
- Provide the basic descriptive information that is necessary for planning future studies.
Detailed description
A seizure or convulsion is a paroxysmal, time-limited change in motor activity and/or behavior that results from abnormal electrical activity in the brain .
The International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE) have come to consensus definitions for the terms epileptic seizure and epilepsy, An epileptic seizure is a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain but epilepsy is a disorder of the brain characterized by an enduring predisposition to generate epileptic seizures and by the neurobiologic, cognitive, psychological, and social consequences of this condition.
Approximately 4-10% of children experience at least one seizure (febrile or a febrile) in the 1st 16 yr of life, the cumulative lifetime incidence of epilepsy is 3%, and more than half of the cases start in childhood.
Seizure disorder is a general term that is usually used to include any of several disorders, including epilepsy, febrile seizures, and possibly single seizures and symptomatic seizures secondary to metabolic, infectious, or other etiologies (e.g., hypocalcaemia,meningitis).
In the International League Against Epilepsy (ILAE) classification of etiology of epilepsy, idiopathic epilepsy which occur without organic cause, and symptomatic epilepsy that associated with underlying brain disorder that may or may not be genetic .
The definition of epilepsy requires the occurrence of 2 or more unprovoked seizures occur in a time frame of longer than 24 hr .
There are 2 main types of seizures: generalized and focal, focal seizures are those arising within networks of a single cerebral hemisphere and may remain localized or subsequently become more widely distributed.
Generalized seizures rapidly affect both hemispheres as well as both sides of the body even when caused by a "focal" lesion.
Focal (formerly known as partial) seizures are subdivided into simple partial seizures which is refers to focal seizures with no alteration in consciousness and complex partial seizures associated with altered awareness of the surroundings.
Generalized seizures are further subdivided to tonic (sustained contraction), clonic (rhythmic contractions), myoclonic (rapid shock-like contractions, usually<50 msec in duration, that may be isolated or may repeat but usually are not rhythmic), atonic, or astatic (cause avery momentary loss of tone with sudden fall ) Absence seizures (generalized seizures consisting of staring, unresponsiveness, and eye flutter lasting usually for few seconds).
Seizures triggered by fever, defined as febrile seizures, have been for decades a major issue for children in developed countries Epidemiologic studies have led to the division of febrile seizures into 3 groups, as follows:
- Simple febrile seizures
- Complex febrile seizures
- Symptomatic febrile seizures In Simple febrile seizure is single generalized seizure and lasts less than 15 minutes, The child is otherwise neurologically healthy and without neurologic abnormality by examination or by developmental history and not caused by meningitis, encephalitis, or any other illness affecting the brain .
Complex febrile seizure: This seizure is either focal or prolonged (ie, >15 min), or multiple seizures occur in close succession.
Symptomatic febrile seizure: The child has a preexisting neurologic abnormality or acute illness.
Although the outlook for most children with symptomatic seizures or those associated with epilepsy is generally good, seizures may signal a potentially serious underlying systemic or central nervous system (CNS) disorder that requires thorough investigation and management.
Children may have behaviors that are easily mistaken for epileptic Seizures but are not , these include breath-holding spells ,bed wetting ,night terrors ,tics.
Gastroesophageal reflux may cause arching of the back and twisting of the head to the side in infants, which may be mistaken for tonic-clonic seizures, misdiagnosis is frequent (occurring in about 5 to 30% of cases) .
Descriptive epidemiology of pediatric seizures is important for:
First, knowledge of health care utilization is essential for planning and management.
This study will be carried to:
- Describe the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies .
- Provide the basic descriptive information that is necessary for planning future studies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Area of study: Pediatric department at Al-Arish central hospital in North Sinai. Descriptive cross sectional hospital based study. Data will be collected from patient using semi structured questionnaire through interview with patient care giver.
Key inclusion criteria (1 listed)
- Patients from 2 months upto 18 years of age with seizures admitted to Al-Arish central Hospital .
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| No drug interventionThis study will be performed in Al-Arish Central Hospital and will include all patients from 2 months up to 18 years of age with seizures admitted to Al-Arish Central Hospital | Other | – |
Primary outcome
Description of the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies .
Time frame: 1 year
Descriptive cross sectional study Data will be collected from patient using semi structured questionnaire through interview with patient care giver. Data will be entered, cleaned and analyzed using statistical software program (SPSS version 20). Descriptive statistics will be presented in the form of percentages for qualitative variables and mean and SD for quantitative data. Qualitative data will be compared using chi-square test, and quantitative data will be compared using Student's t test, other tests will be used as appropriate . P-value will be considered significant if less than0.05 for all statistical tests .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Background: PubMed 3588141Freeman JM, Tibbles J, Camfield C, Camfield P. Benign epilepsy of childhood: a speculation and its ramifications. Pediatrics. 1987 Jun;79(6):864-8.
- Background: PubMed 20196795Berg AT, Berkovic SF, Brodie MJ, Buchhalter J, Cross JH, van Emde Boas W, Engel J, French J, Glauser TA, Mathern GW, Moshe SL, Nordli D, Plouin P, Scheffer IE. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia. 2010 Apr;51(4):676-85. doi: 10.1111/j.1528-1167.2010.02522.x. Epub 2010 Feb 26.
- Background: PubMed 26022778Dalbem JS, Siqueira HH, Espinosa MM, Alvarenga RP. Febrile seizures: a population-based study. J Pediatr (Rio J). 2015 Nov-Dec;91(6):529-34. doi: 10.1016/j.jped.2015.01.005. Epub 2015 May 26.
- Background: PubMed 1760604Verity CM, Golding J. Risk of epilepsy after febrile convulsions: a national cohort study. BMJ. 1991 Nov 30;303(6814):1373-6. doi: 10.1136/bmj.303.6814.1373.
- Background: PubMed 14597491Richards CF, Lowe RA. Researching racial and ethnic disparities in emergency medicine. Acad Emerg Med. 2003 Nov;10(11):1169-75. doi: 10.1111/j.1553-2712.2003.tb00599.x.
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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.
Ehsan mr Saeid, RD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Convulsive Seizures, run by Ehsan M saied.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehsan ms Saeid, RD (00201028717600, saiedehsan5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the pattern of seizures among cases admitted to Pediatric department at Al-Arish central hospital in North Sinai and compare results with national and international similar studies . (time frame: 1 year). 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 NCT03374384, which also lists 5 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 26 Nov 2019.