Management and Clinical Outcome of Neonatal Arrhythmias

Not yet recruiting

• Conditions: Neonatal Arrhythmias

• Registration Number: NCT06705621
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2024-09-11
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2025-01-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment	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	Baseline	Management of neonatal arrhythmias in Assiut University Children's Hospital based on ECG and lab investigation

Secondary Outcome Measures

Name	Time	Method
Investigation	Baseline	(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