NCT Number: NCT06705621
Management and Clinical Outcome of Neonatal Arrhythmias
assess the Management and clinical outcome of neonatal arrhythmia
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
1 day–28 day
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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 .
Treatment and study plan
Primary outcomes
-
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
Secondary outcomes
-
Investigation
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Faisel -Alkhateeb Ahmed Abdullah, Professor
CONTACT
Manar Abdel-menem Fouad, Resident
CONTACT
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Official study title
Management and Clinical Outcome of Neonatal Arrhythmias in Assuit University Children's Hospital
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 26, 2024
- Registry last updated
- Nov 26, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.