Clinical Profile of Neonates Having Patent Ductus Arteriosus

March 3, 2021 updated by: Martina Emad Amin, Assiut University

Clinical Profile of Neonates Diagnosed by Echocardiography as Having Patent Ductus Arteriousus in Assiut University Hospital for Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Salah - Eldin Amry Ahmad, professor
  • Phone Number: 01550855453
  • Email: S_amry@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 weeks (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the percentage of cases with PDA admitted to our neonatology unit per year.
Time Frame: one year
This study was proposed to improve practice in our neonatal unit regarding interpretation of echocardiograms showing the diagnosis of PDA and decisions based on.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

February 1, 2022

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDA in neonatology

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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