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

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 Overview

• Status: Not yet recruiting
• Conditions: Seizures
• Intervention / Treatment: Device: ECG

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Amany K El Zanaty, resident; Phone Number: 01000465897; Email: amanykhalaf@med.sohag.edu.eg
• Study Contact Backup: Name: Mohamed M Fawaz, professor

Study Locations

• Egypt
  • Sohag, Egypt, Sohag
    • Sohag University Hospital
    • Contact: Magdy M Amin, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): September 25, 2023
• Primary Completion (Estimated): September 25, 2024
• Study Completion (Estimated): September 25, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: Soh-Med-23-09-06MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No