A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital
1 other identifier
observational
100
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 12, 2022
April 1, 2022
1 year
March 28, 2022
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
heart rate
normal values according to age and sex.
one year
Secondary Outcomes (1)
PR interval
one year
Other Outcomes (1)
QTC
one year
Study Arms (9)
children with epilepsy
epilepsy diagnosed clinically EEG
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
children with cns infection
the child has fever, neck, rigidity DCL +or- CSF analysis
children with electrolyte imbalance, hypoglycemia
abnormal values of electrolyte hypoglycemia
children with poisoning
history of ingestion or inhalation of toxic substance
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.
children with trauma
history of trauma imaging study done
children with genetic cause
the child has congenital anomaly as chromosomal abnormality, metabolic disease, mitochondrial disease
others
children not fulfilling the previous groups
Interventions
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
Eligibility Criteria
All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.
You may qualify if:
- All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Related 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.
PMID: 34332536BACKGROUNDRijnbeek 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.
PMID: 11781941BACKGROUNDKarjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71.
PMID: 2424378BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor at pediateric department sohag general hospital
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 12, 2022
Study Start
April 1, 2022
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
April 12, 2022
Record last verified: 2022-04