Clinical Profile of Neonates Having Patent Ductus Arteriosus
NCT ID: NCT04672629
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
30 participants
OBSERVATIONAL
2021-04-01
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Hemodynamic Assessment in Shocked Patients in the Pediatric Intensive Care Unit
NCT06720493
Evaluation of Electrical Velocimetry for Assessment of Extra-vascular Lung Water in Pre-eclamptic Patients
NCT03127865
PVF in Decongestion of Heart Failure
NCT05227872
Study of Hemodynamics of Neonates by Echocardiography and USCOM
NCT01045252
NT-proBNP and Troponin I in Dengue Children
NCT04837430
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The ductus arteriosus is a blood vessel that connects the two major arteries, namely the aorta and the pulmonary artery, and is essential in maintaining circulation in fetal life. After the baby is born and the fetal circulation changes to adult circulation, the ductus arteriosus functionally closes between 18 and 24 hours of life (1 ).
The arterial duct is a fetal blood vessel that is programmed to close shortly after birth. If the vessel remains patent beyond 3 months of life (a persistently patent arterial duct) it can result in volume loading of the left heart and should be closed either surgically or by a catheter-based procedure. A patent arterial duct is common in the newborn, particularly premature infants, and can contribute to persistent respiratory problems. (2) Historical estimates have placed the incidence of isolated PDA at approximately 0.05% of all live births. Isolated PDA accounts for 5% to 10% of congenital heart defects (3) number most likely represents the prevalence of a "symptomatic" PDA-that is, one that results in evidence of increased pulmonary blood flow, left heart volume overload, elevated PA pressure, murmur, etc. With the advent of color Doppler echocardiography, the incidental recognition of asymptomatic "silent" ductus has become more common. Some have estimated the prevalence of silent PDA among children and adults to be up to 0.5%, far more common than the "symptomatic" PDA (4).
However, in babies born prematurely, the ductus arteriosus often fails to close spontaneously and leads to a number of morbidities. it has been shown that in infants born with a birth weight of \<1000 g, the ductus arteriosus remains open in 66% of infants beyond the first week of life. In the extreme premature population born at 24 weeks of gestation, only 13% of infants are found to have their ductus closed by the end of the first week (5).This makes PDA an important issue from the clinical management perspective in the first few days of life in preterm infants.
It is associated with a number of comorbidities such as necrotising enterocolitis (NEC), bronchopulmonary dysplasia and intraventricular haemorrhage (IVH) (6-7).
The management controversy has mainly focused on when to treat and with what to treat. To increase the complexity of m atters, these two aspects of PDA management are not mutually exclusive, with the modality of treatment often being dictated by the timing of treatment. There have been a large number of published studies, meta-analyses and editorials focusing on different aspects of management.(8-9)Regarding the timing of treatment, prophylactic therapy has gradually fallen out of favor and neonatal units have shifted towards a more conservative approach by treating only the clinically and echocardiographically (ECHO) significant PDA (10).However, the big dilemma that still persists among neonatologists is what to use as the primary modality of treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
echocardiography
follow up echocardiography
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2- Absence of other congenital cardiac defects.
Exclusion Criteria
0 Days
28 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Martina Emad Amin
doctor
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Vettukattil JJ. Pathophysiology of Patent Ductus Arteriosus in the Preterm Infant. Curr Pediatr Rev. 2016;12(2):120-2. doi: 10.2174/157339631202160506002215.
Louis D, ElSayed YN, Ojah C, Alvaro R, Shah PS, Dunn M; Canadian Neonatal Network Investigators. Predictors of PDA Treatment in Preterm Neonates Who Had Received Prophylactic Indomethacin. Am J Perinatol. 2018 Apr;35(5):509-514. doi: 10.1055/s-0037-1608792. Epub 2017 Nov 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PDA in neonatology
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.