Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
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ClinicalTrials.gov Identifier: NCT06045676 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 28, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Seizures | Device: ECG |
Study Type : | Observational |
Estimated Enrollment : | 160 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital |
Estimated Study Start Date : | September 25, 2023 |
Estimated Primary Completion Date : | September 25, 2024 |
Estimated Study Completion Date : | September 25, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Drug Resistant Epilepsy
Seizures Not Respond to two lines of Anti epileptic Medications
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Device: ECG
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. |
Drug Responsive Epilepsy
Seizures Respond to one or two lines of Anti epileptic Medications
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Device: ECG
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. |
Febrile Seizures
type of seizure occurring due to fever over 38 °C without a history of convulsion
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Device: ECG
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. |
Breath Holding Spells
children's behaviors look like epileptic seizures due to crying up to a minute followed by losing consciousness
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Device: ECG
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. |
Control
Healthy Children free from any convulsion
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Device: ECG
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. |
- 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
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Ages Eligible for Study: | 1 Year to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- children with drug resistant epilepsy.
- febrile seizures.
- age of 1 year to 12 years.
Exclusion Criteria:
- age below 1 year and above 12 years
- children with convulsion secondary cns infection , encephalitis, encephalopathy , toxic and metabolic problem
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045676
Contact: Amany K El Zanaty, resident | 01000465897 | amanykhalaf@med.sohag.edu.eg | |
Contact: Mohamed M Fawaz, professor |
Egypt | |
Sohag university Hospital | |
Sohag, Egypt, Sohag | |
Contact: Magdy M Amin, professor |
Responsible Party: | Amany Khalaf Allah Elzanaty, Resident, Sohag University |
ClinicalTrials.gov Identifier: | NCT06045676 |
Other Study ID Numbers: |
Soh-Med-23-09-06MS |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 28, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Seizures Neurologic Manifestations Nervous System Diseases |