Patent Ductus ArteriosusNCT04672629
Clinical Profile of Neonates Having Patent Ductus Arteriosus
An observational study of Patent Ductus Arteriosus, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- echocardiography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Child
Study population: 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated
Who may be able to join
- 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated.
- 2- Absence of other congenital cardiac defects.
Who cannot join
- PDA associated with other cardiac anomalies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- echocardiography
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDevice
follow up echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of cases with PDA admitted to our neonatology unit per 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Emad Amin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672629
- Sponsor's protocol ID
- PDA in neonatology
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vettukattil JJ. Pathophysiology of Patent Ductus Arteriosus in the Preterm Infant. Curr Pediatr Rev. 2016;12(2):120-2. doi: 10.2174/157339631202160506002215.
PubMed 27197953Louis 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.
PubMed 29183097
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile of Neonates Diagnosed by Echocardiography as Having Patent Ductus Arteriousus in Assiut University Hospital for Children
- ClinicalTrials.gov ID
- NCT04672629
- Acronym / sponsor ID
- PDA in neonatology
- Conditions
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated
Key inclusion criteria (2 listed)
- 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated.
- 2- Absence of other congenital cardiac defects.
Key exclusion criteria (1 listed)
- PDA associated with other cardiac anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyfollow up echocardiography | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 27197953Vettukattil JJ. Pathophysiology of Patent Ductus Arteriosus in the Preterm Infant. Curr Pediatr Rev. 2016;12(2):120-2. doi: 10.2174/157339631202160506002215.
- Background: PubMed 29183097Louis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Emad Amin, doctor (01016940909, Martinaemad1411@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the percentage of cases with PDA admitted to our neonatology unit per year. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.