Management and Clinical Outcome of Neonatal Arrhythmias

NCT ID: NCT06705621

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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assess the Management and clinical outcome of neonatal arrhythmia

Detailed Description

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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

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Neonatal Arrhythmias

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Neonates up to 28 day with arrhythmia except premature atrial contraction.

Exclusion Criteria

* More than 28 day
* Neonates with other diseases other than arrhythmia .
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Manar Abdel-menem Fouad

71515,Assiut

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Manar Abdel-menem Fouad, Resident

Role: CONTACT

+201029151481

Faisel -Alkhateeb Ahmed Abdullah, Professor

Role: CONTACT

01003858676

References

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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.

Reference Type BACKGROUND
PMID: 38374353 (View on PubMed)

Kundak 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.

Reference Type BACKGROUND
PMID: 23054850 (View on PubMed)

Badrawi 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.

Reference Type BACKGROUND
PMID: 19184182 (View on PubMed)

Other Identifiers

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neonatal arrhythmias

Identifier Type: -

Identifier Source: org_study_id

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