ConvulsionsNCT05322772
A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital
An observational study of Convulsions, run by Sohag University.
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Convulsions
- What is being tested?
- ECG
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Child, Adult
Study population: All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.
Who may be able to join
- All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Convulsions
- Being tested
- ECG
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDevice
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
| Study group | Role | What they receive |
|---|---|---|
| children with epilepsy | epilepsy diagnosed clinically EEG Receives: Device: ECG | |
| 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 Receives: Device: ECG | |
| children with cns infection | the child has fever, neck, rigidity DCL
+or- CSF analysis Receives: Device: ECG | |
| children with electrolyte imbalance, hypoglycemia | abnormal values of electrolyte hypoglycemia Receives: Device: ECG | |
| children with poisoning | history of ingestion or inhalation of toxic substance Receives: Device: ECG | |
| 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. Receives: Device: ECG | |
| children with trauma | history of trauma imaging study done Receives: Device: ECG | |
| children with genetic cause | the child has congenital anomaly as chromosomal abnormality, metabolic disease, mitochondrial disease Receives: Device: ECG | |
| others | children not fulfilling the previous groups Receives: Device: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
normal values according to age and sex.
Measured: one year
Secondary outcomes (1)
PR interval
normal values according to age and sex.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConvulsionsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Aiman Sadek, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322772
- Sponsor's protocol ID
- Soh-Med-22-03-05
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34332536Rijnbeek 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.
PubMed 11781941Karjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71.
PubMed 2424378
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05322772
- Acronym / sponsor ID
- Soh-Med-22-03-05
- Conditions
- Convulsions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| children with epilepsy | – | Device: ECGepilepsy diagnosed clinically EEG |
| children with febrile convulsions | – | Device: ECGthe 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 | – | Device: ECGthe child has fever, neck, rigidity DCL +or- CSF analysis |
| children with electrolyte imbalance, hypoglycemia | – | Device: ECGabnormal values of electrolyte hypoglycemia |
| children with poisoning | – | Device: ECGhistory of ingestion or inhalation of toxic substance |
| children with encephalopathy | – | Device: ECGthe 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 | – | Device: ECGhistory of trauma imaging study done |
| children with genetic cause | – | Device: ECGthe child has congenital anomaly as chromosomal abnormality, metabolic disease, mitochondrial disease |
| others | – | Device: ECGchildren not fulfilling the previous groups |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.
Key inclusion criteria (1 listed)
- All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGii. 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 | Device | children with cns infection, children with electrolyte imbalance, hypoglycemia, children with encephalopathy, children with epilepsy, children with febrile convulsions, children with genetic cause, children with poisoning, children with trauma, others |
Primary outcome
heart rate
Time frame: one year
normal values according to age and sex.
1 secondary outcome
PR interval
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Background: PubMed 34332536Huang 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.
- Background: PubMed 11781941Rijnbeek 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.
- Background: PubMed 2424378Karjalainen J, Viitasalo M. Fever and cardiac rhythm. Arch Intern Med. 1986 Jun;146(6):1169-71.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Convulsions, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman A Sadek (01156556464 ext. 002, eman011064@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.