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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06045676
Other study ID # Soh-Med-23-09-06MS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date September 25, 2024

Study information

Verified date September 2023
Source Sohag University
Contact Amany K El Zanaty, resident
Phone 01000465897
Email amanykhalaf@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date September 25, 2024
Est. primary completion date September 25, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Sohag university Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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