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NCT Number: NCT06705621

Management and Clinical Outcome of Neonatal Arrhythmias

assess the Management and clinical outcome of neonatal arrhythmia

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Key information

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

  1. 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

  2. Management of arrhythmias

    Time frame: Baseline

    Management of neonatal arrhythmias in Assiut University Children's Hospital based on ECG and lab investigation

Secondary outcomes

  1. 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

[email protected]

01003858676

Manar Abdel-menem Fouad, Resident

CONTACT

[email protected]

+201029151481

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.