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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ehsan ms Saeid, RD contact

00201028717600

saiedehsan5@gmail.com

Emad El-Deen mr Hammad, Professor contact

01223559943

Emadeldaly2003@yahoo.com

About this study

Official title: Pattern of Pediatric Seizures at Al-Arish Central Hospital - North Sinai

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 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:

  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.
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.

  1. 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.

  1. First posted15 Dec 2017
  2. Study start1 Dec 2019 (estimated)
  3. Primary completion30 Apr 2020 (estimated)
  4. Study completion24 Aug 2020 (estimated)

Resources

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
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 3588141
  • Berg 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 20196795
  • Dalbem 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 26022778
  • Verity 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 1760604
  • Richards 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

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.

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