Brief Title
Clinical Profile of Neonates Having Patent Ductus Arteriosus
Official Title
Clinical Profile of Neonates Diagnosed by Echocardiography as Having Patent Ductus Arteriousus in Assiut University Hospital for Children
Brief Summary
The study aims to evaluate the clinical presentation and course of PDA diagnosed at neonatal
period in the neonatology unit of Assiut University Hospital for Children.
Detailed Description
One of the most common cardiovascular problems that prematurely born infants experience early
in life is patent ductus arteriosus (PDA).
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.
Study Type
Observational
Primary Outcome
Determine the percentage of cases with PDA admitted to our neonatology unit per year.
Condition
Patent Ductus Arteriosus
Intervention
echocardiography
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
January 1, 2021
Completion Date
February 2022
Primary Completion Date
January 1, 2022
Eligibility Criteria
Inclusion Criteria:
- 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom
echocardiography is indicated.
2- Absence of other congenital cardiac defects.
Exclusion Criteria:
- PDA associated with other cardiac anomalies.
Gender
All
Ages
N/A - 28 Days
Contacts
, 01016940909, [email protected]
Administrative Informations
NCT ID
NCT04672629
Organization ID
PDA in neonatology
Responsible Party
Principal Investigator
Study Sponsor
Assiut University
Study Sponsor
, ,
Verification Date
December 2020