The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045676
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Amany Khalaf Allah Elzanaty, Sohag University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Drug Resistant Epilepsy
Seizures Not Respond to two lines of Anti epileptic Medications
 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
 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
 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
 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
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children with drug resistant epilepsy , responsive epilepsy , febrile seizures and breath holding spells with age of 1 year to 12 years
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Amany K El Zanaty, resident 01000465897 amanykhalaf@med.sohag.edu.eg
Contact: Mohamed M Fawaz, professor

Locations
Layout table for location information
Egypt
Sohag university Hospital
Sohag, Egypt, Sohag
Contact: Magdy M Amin, professor         
Sponsors and Collaborators
Sohag University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Seizures
Neurologic Manifestations
Nervous System Diseases