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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06045676
Collaborator
(none)
160
1
12
13.3

Study Details

Study Description

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 Phase
  • Device: ECG

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Sep 25, 2023
Anticipated Primary Completion Date :
Sep 25, 2024
Anticipated Study Completion Date :
Sep 25, 2024

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. QT interval [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

Criteria

Ages Eligible for Study:
1 Year to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • children with drug resistant epilepsy , responsive epilepsy , febrile seizures and breath holding spells with 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

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt Sohag

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amany Khalaf Allah Elzanaty, Resident-pediatric department-sohag hospital university, Sohag University
ClinicalTrials.gov Identifier:
NCT06045676
Other Study ID Numbers:
  • Soh-Med-23-09-06MS
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023