Neonatal ArrhythmiasNCT06705621
Management and Clinical Outcome of Neonatal Arrhythmias
An observational study of Neonatal Arrhythmias, run by Assiut University.
Trial summary
assess the Management and clinical outcome of neonatal arrhythmia Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Arrhythmias
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 day to 28 days
- All sexes
- Child
Study population: assess theIncidence, .Management and clinical outcome of neonatal arrhythmia .
Who may be able to join
- Neonates up to 28 day with arrhythmia except premature atrial contraction.
Who cannot join
- More than 28 day
- Neonates with other diseases other than arrhythmia .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Management and Clinical Outcome of Neonatal Arrhythmias in Assuit University Children's Hospital
assess the Management and clinical outcome of neonatal arrhythmia
Read the detailed description
Cardiac arrhythmia is a significant cardiovascular disorder in the neonatal period and can result in infant mortality if not diagnosed or treated promptly. The incidence of arrhythmia is about 0.1% to 4.8% during the neonatal period. In neonatal intensive care units (NICUs), the incidence of cardiac arrhythmia could reach 10%. Approximately 1% to 3% of fetal
- cardiac arrhythmias were detected during pregnancy The clinical presentation of NA is variable. Some neonates do not become symptomatic, and could not be diagnosed during
- neonatal period, whereas others may develop signs of congestive heart failure and cardiogenic shock even before birth The most common significant arrhythmia is supraventricular tachycardia (SVT), but atrial flutter (AFL), various forms of atrioventricular block (AVB), and ventricular tachycardia (VT) may also occur. Because of the immature physiology of
- the fetal and neonatal myocardium, heart failure may occur at either abnormally low or high ventricular rates
- The electrocardiogram (ECG) is the gold standard for identifying problems with heart rate and regularity. However investigations of arrhythmias were hampered by their transitory nature. Monitoring rhythm patterns over extended duration makes Holter monitors a very helpful complementary noninvasive tool in the diagnosis of cardiac arrhythmias. It allows the cumulative evaluation of heart rhythm and rhythm variability, which is important in diagnosing silent and episodic
- arrhythmias in high-risk groups Medical management of SVT consists of a trial of vagal maneuvers, adenosine, and medications to maintain sinus rhythm such as beta blockers and class I or class III antiarrhythmic medications. For neonates who have hemodynamically
- significant SVT, frequent SVT requiring medical management, pre-excitation on ECG, or congenital cardiac defect chronic medical treatment is appropriate. AF is common in newborns, usually in structurally normal hearts, and long term medical therapy besides initial conversion to sinus rhythm is usually not needed, given the low probability of recurrence
- the prognosis depends on the early recognition and proper management of the condition in some serious neonatal cases Precise diagnosis with risk stratification of patients with non-benign neonatal arrhythmia is needed to reduce morbidity and mortality.
- Conditions
- Neonatal Arrhythmias
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment
Assessment of clinical outcomes of neonatal arrhythmias at Assiut University Children's Hospital , If cases will die or become completely free or survive with some problems and if become on treatment or not
Measured: Baseline
Management of arrhythmias
Management of neonatal arrhythmias in Assiut University Children's Hospital based on ECG and lab investigation
Measured: Baseline
Secondary outcomes (1)
Investigation
(12- lead ECG including three lead rhythm strip)
- Insure that the rhythm and QTC will be calculated.
- Checking urea and electrolytes, serum calcium, magnesium and blood sugar.
- ECHO Cardioghraphy will be considered if there is a suspension on Clinical examination of structural Congenital Heart disease (mummer, absence of femoral pulse).
- It will also be considered if there are frequent ventricular premature couplet.
- Any infant who is symptomatic for Congenital or cyanotic cardiac disease or congestive cardiac failure will be immediately admitted to the neonatal unit and managed according to their clinical condition
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (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 Neonatal ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Abdel-menem Fouad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705621
- Sponsor's protocol ID
- neonatal arrhythmias
- Status last verified
- Nov 2024
- First submitted
- 11 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Na J, Wu S, Chen L, Qi Y, Yuan Y, Feng G, Wang X, Hei M. Clinical Outcomes and Medical Burdens of Neonatal Arrhythmias in Children's Hospitals in China: A Protocol for Multi-Center Retrospective Cohort Study. Pediatr Cardiol. 2024 Apr;45(4):814-820. doi: 10.1007/s00246-024-03421-z. Epub 2024 Feb 19.
PubMed 38374353Kundak AA, Dilli D, Karagol B, Karadag N, Zenciroglu A, Okumus N, Dogan V, Uzunalic N. Non benign neonatal arrhythmias observed in a tertiary neonatal intensive care unit. Indian J Pediatr. 2013 Jul;80(7):555-9. doi: 10.1007/s12098-012-0852-3. Epub 2012 Oct 4.
PubMed 23054850Badrawi N, Hegazy RA, Tokovic E, Lotfy W, Mahmoud F, Aly H. Arrhythmia in the neonatal intensive care unit. Pediatr Cardiol. 2009 Apr;30(3):325-30. doi: 10.1007/s00246-008-9355-4. Epub 2009 Jan 30.
PubMed 19184182
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Clinical Outcome of Neonatal Arrhythmias in Assuit University Children's Hospital
- ClinicalTrials.gov ID
- NCT06705621
- Acronym / sponsor ID
- neonatal arrhythmias
- Conditions
- Neonatal Arrhythmias
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Nov 2024 (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.
assess the Management and clinical outcome of neonatal arrhythmia
Detailed description
Cardiac arrhythmia is a significant cardiovascular disorder in the neonatal period and can result in infant mortality if not diagnosed or treated promptly. The incidence of arrhythmia is about 0.1% to 4.8% during the neonatal period. In neonatal intensive care units (NICUs), the incidence of cardiac arrhythmia could reach 10%. Approximately 1% to 3% of fetal
- cardiac arrhythmias were detected during pregnancy The clinical presentation of NA is variable. Some neonates do not become symptomatic, and could not be diagnosed during
- neonatal period, whereas others may develop signs of congestive heart failure and cardiogenic shock even before birth The most common significant arrhythmia is supraventricular tachycardia (SVT), but atrial flutter (AFL), various forms of atrioventricular block (AVB), and ventricular tachycardia (VT) may also occur. Because of the immature physiology of
- the fetal and neonatal myocardium, heart failure may occur at either abnormally low or high ventricular rates
- The electrocardiogram (ECG) is the gold standard for identifying problems with heart rate and regularity. However investigations of arrhythmias were hampered by their transitory nature. Monitoring rhythm patterns over extended duration makes Holter monitors a very helpful complementary noninvasive tool in the diagnosis of cardiac arrhythmias. It allows the cumulative evaluation of heart rhythm and rhythm variability, which is important in diagnosing silent and episodic
- arrhythmias in high-risk groups Medical management of SVT consists of a trial of vagal maneuvers, adenosine, and medications to maintain sinus rhythm such as beta blockers and class I or class III antiarrhythmic medications. For neonates who have hemodynamically
- significant SVT, frequent SVT requiring medical management, pre-excitation on ECG, or congenital cardiac defect chronic medical treatment is appropriate. AF is common in newborns, usually in structurally normal hearts, and long term medical therapy besides initial conversion to sinus rhythm is usually not needed, given the low probability of recurrence
- the prognosis depends on the early recognition and proper management of the condition in some serious neonatal cases Precise diagnosis with risk stratification of patients with non-benign neonatal arrhythmia is needed to reduce morbidity and mortality.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- assess theIncidence, .Management and clinical outcome of neonatal arrhythmia .
Key inclusion criteria (1 listed)
- Neonates up to 28 day with arrhythmia except premature atrial contraction.
Key exclusion criteria (2 listed)
- More than 28 day
- Neonates with other diseases other than arrhythmia .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment
Time frame: Baseline
Assessment of clinical outcomes of neonatal arrhythmias at Assiut University Children's Hospital , If cases will die or become completely free or survive with some problems and if become on treatment or not
Management of arrhythmias
Time frame: Baseline
Management of neonatal arrhythmias in Assiut University Children's Hospital based on ECG and lab investigation
1 secondary outcome
Investigation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 38374353Na J, Wu S, Chen L, Qi Y, Yuan Y, Feng G, Wang X, Hei M. Clinical Outcomes and Medical Burdens of Neonatal Arrhythmias in Children's Hospitals in China: A Protocol for Multi-Center Retrospective Cohort Study. Pediatr Cardiol. 2024 Apr;45(4):814-820. doi: 10.1007/s00246-024-03421-z. Epub 2024 Feb 19.
- Background: PubMed 23054850Kundak AA, Dilli D, Karagol B, Karadag N, Zenciroglu A, Okumus N, Dogan V, Uzunalic N. Non benign neonatal arrhythmias observed in a tertiary neonatal intensive care unit. Indian J Pediatr. 2013 Jul;80(7):555-9. doi: 10.1007/s12098-012-0852-3. Epub 2012 Oct 4.
- Background: PubMed 19184182Badrawi N, Hegazy RA, Tokovic E, Lotfy W, Mahmoud F, Aly H. Arrhythmia in the neonatal intensive care unit. Pediatr Cardiol. 2009 Apr;30(3):325-30. doi: 10.1007/s00246-008-9355-4. Epub 2009 Jan 30.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Arrhythmias, run by Assiut 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: opening soon, as of the sponsor's last update on 26 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar Abdel-menem Fouad, Resident (+201029151481, manar.fouad.98.mf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT06705621, 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 26 Nov 2024.