A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital

Convulsions Clinical Trial

Official title:

A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05322772
• Other study ID #: Soh-Med-22-03-05
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: April 2023

Study information

• Verified date: April 2022
• Source: Sohag University
• Contact: Eman A Sadek
• Phone: 01156556464
• Email: eman011064[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Convulsion is a common pediatric disorder and there is strong relation between convulsion and cardiovascular system which revealed by ECG monitoring and there are many ECG abnormalities attributed to different causes of convulsions, A 12-lead ECG is a low-cost test and can detect clinically significant abnormalities such as long QTc interval or heart block. Doing an ECG in all patients presenting with seizures clinic, inevitably, pick up non-specific abnormalities which require further investigation. Moreover, a normal 12-lead ECG does not exclude a cardiovascular cause for collapse and for those in whom a cardiac cause is still suspected despite a normal ECG, referral to a cardiologist is advisable

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.

Exclusion Criteria:

• Children not filling the criteria of convulsions (like conditions mimic epilepsy)

• Children with known cardiac disease or cardiac arrhythmia and patients who will not give consent will be excluded.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Convulsions
• Seizures

Intervention

Device:
• ECG
ii. 12 leads ECG: 12 leads ECG will be done to all infants & children using (FUKUDA DENSHI, CARDIMAX, model FCP 7101). The electrocardiograms will be reviewed through the creation of descriptive reports and determination of the following variables: heart rate, QRS duration, The QT interval was measured from the onset of the QRS complex to the end of the T wave, defined by the return of the terminal T wave to the isoelectric T-P baseline. When U waves were present, the end of the T wave will be taken as the nadir between the T and U waves. Then QT interval will be corrected for heart rate using Bazett's formula Interpretation of every ECG paper

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (3)

Huang X, Malek N, Simpson J, Kalladka D, Dunn FG, Leach JP. Winning hearts and minds: ECG reporting in the first seizure clinic. BMC Cardiovasc Disord. 2021 Jul 31;21(1):364. doi: 10.1186/s12872-021-02174-4. — View Citation

Karjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71. — View Citation

Rijnbeek PR, Witsenburg M, Szatmari A, Hess J, Kors JA. PEDMEANS: a computer program for the interpretation of pediatric electrocardiograms. J Electrocardiol. 2001;34 Suppl:85-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QTC	normal values according to age and sex.	one year
Primary	heart rate	normal values according to age and sex.	one year
Secondary	PR interval	normal values according to age and sex.	one year