SeizuresNCT06045676
Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
An observational study of Seizures, run by Sohag University at 1 site in Egypt.
Trial summary
Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Seizures
- What is being tested?
- ECG
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2023to 25 Sep 2024
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children with drug resistant epilepsy , responsive epilepsy , febrile seizures and breath holding spells with age of 1 year to 12 years
Who may be able to join
- children with drug resistant epilepsy.
- febrile seizures.
- age of 1 year to 12 years.
Who cannot join
- age below 1 year and above 12 years
- children with convulsion secondary cns infection , encephalitis, encephalopathy , toxic and metabolic problem
Trial locations and contacts
1 site in 1 country.
Mohamed M Fawaz, professor contact
About this study
Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours. Febrile Convulsion is another type of seizure occurring due to fever over 38 °C without a history of convulsion, CNS infection, electrolyte imbalance, metabolic disorder, intoxication, and trauma. Unlike epileptic seizures, there are non-epileptic seizures such as Breath Holding Spells that affect children's behaviors and often look like epileptic seizures.
QT parameters elongation show the danger of dysrhythmia and unexpected sicknesses such as cardiomyopathy, mitral valve prolapse, ischemic coronary illness, and kidney disorders.
Many investigators have reported changes in QT parameters in various diseases such as diabetes mellitus, celiac disease, thalassemia , epilepsy ,Breath holding spells and febrile seizure.
- Conditions
- Seizures
- Being tested
- ECG
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDevice
ECG with special comment on QT interval. QT interval was measured as the distance from the beginning of the Q wave to the end of the T wave at least in eight leads from the standard ECG.
| Study group | Role | What they receive |
|---|---|---|
| Drug Resistant Epilepsy | Seizures Not Respond to two lines of Anti epileptic Medications Receives: Device: ECG | |
| Drug Responsive Epilepsy | Seizures Respond to one or two lines of Anti epileptic Medications Receives: Device: ECG | |
| Febrile Seizures | type of seizure occurring due to fever over 38 °C without a history of convulsion Receives: Device: ECG | |
| Breath Holding Spells | children's behaviors look like epileptic seizures due to crying up to a minute followed by losing consciousness Receives: Device: ECG | |
| Control | Healthy Children free from any convulsion Receives: Device: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT interval
Distance from the beginning of the Q wave to the end of the T wave at least in eight leads from the standard ECG
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Sep 2023 (estimated)
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Khalaf Allah Elzanaty, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045676
- Sponsor's protocol ID
- Soh-Med-23-09-06MS
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06045676
- Acronym / sponsor ID
- Soh-Med-23-09-06MS
- Conditions
- Seizures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours. Febrile Convulsion is another type of seizure occurring due to fever over 38 °C without a history of convulsion, CNS infection, electrolyte imbalance, metabolic disorder, intoxication, and trauma. Unlike epileptic seizures, there are non-epileptic seizures such as Breath Holding Spells that affect children's behaviors and often look like epileptic seizures.
QT parameters elongation show the danger of dysrhythmia and unexpected sicknesses such as cardiomyopathy, mitral valve prolapse, ischemic coronary illness, and kidney disorders.
Many investigators have reported changes in QT parameters in various diseases such as diabetes mellitus, celiac disease, thalassemia , epilepsy ,Breath holding spells and febrile seizure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Drug Resistant Epilepsy | – | Device: ECGSeizures Not Respond to two lines of Anti epileptic Medications |
| Drug Responsive Epilepsy | – | Device: ECGSeizures Respond to one or two lines of Anti epileptic Medications |
| Febrile Seizures | – | Device: ECGtype of seizure occurring due to fever over 38 °C without a history of convulsion |
| Breath Holding Spells | – | Device: ECGchildren's behaviors look like epileptic seizures due to crying up to a minute followed by losing consciousness |
| Control | – | Device: ECGHealthy Children free from any convulsion |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with drug resistant epilepsy , responsive epilepsy , febrile seizures and breath holding spells with age of 1 year to 12 years
Key inclusion criteria (3 listed)
- children with drug resistant epilepsy.
- febrile seizures.
- age of 1 year to 12 years.
Key exclusion criteria (2 listed)
- age below 1 year and above 12 years
- children with convulsion secondary cns infection , encephalitis, encephalopathy , toxic and metabolic problem
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 |
|---|---|---|
| ECGECG with special comment on QT interval. QT interval was measured as the distance from the beginning of the Q wave to the end of the T wave at least in eight leads from the standard ECG. | Device | Breath Holding Spells, Control, Drug Resistant Epilepsy, Drug Responsive Epilepsy, Febrile Seizures |
Primary outcome
QT interval
Time frame: 12 months
Distance from the beginning of the Q wave to the end of the T wave at least in eight leads from the standard ECG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed M Fawaz, professor contact
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 Seizures, run by Sohag University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amany K El Zanaty, resident (01000465897, amanykhalaf@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT interval (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.