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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Eman A Sadek; Phone Number: 002 01156556464; Email: eman011064@med.sohag.edu.eg
• Study Contact Backup: Name: Montaser M Mohamed; Phone Number: 002 01026372799; Email: montaser-dabah@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
children with epilepsy; epilepsy diagnosed clinically EEG	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
children with febrile convulsions; the child has high grade fever from 6 month to 6 years not recurrent duration less than 15 minute or atypical febrile convulsions	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
children with cns infection; the child has fever, neck, rigidity DCL +or- CSF analysis	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
children with electrolyte imbalance, hypoglycemia; abnormal values of electrolyte hypoglycemia	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
children with poisoning; history of ingestion or inhalation of toxic substance	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
children with encephalopathy; the child complains of brain disease or mal function with altered mental status as a complication of primary illness as kidney failure ,cirrhosis, etc.	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
children with trauma; history of trauma imaging study done	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
children with genetic cause; the child has congenital anomaly as chromosomal abnormality, metabolic disease, mitochondrial disease	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
others; children not fulfilling the previous groups	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	normal values according to age and sex.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PR interval	normal values according to age and sex.	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QTC	normal values according to age and sex.	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1054/jelc.2001.28835.
• Karjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (ACTUAL): April 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Arrhythmias, Cardiac; Seizures
• Other Study ID Numbers: Soh-Med-22-03-05

Drug and device information, study documents

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