Clinical trial NCT06705621: Management and Clinical Outcome of Neonatal Arrhythmias
Official title: Management and Clinical Outcome of Neonatal Arrhythmias in Assuit University Children&#39;s Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Arrhythmias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: assess theIncidence, .Management and clinical outcome of neonatal arrhythmia .

Brief summary: 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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Assessment
timeFrame: Baseline
measure: Management of arrhythmias
timeFrame: Baseline
Secondary outcomes:
measure: Investigation
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.