Patency of the Ductus ArteriosusLUNG PDANCT06627374
Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants
An observational study of Patency of the Ductus Arteriosus, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The diagnostic hypothesis is based on the evidence that, while the functional closure of the PDA (Patent Ductus Arteriosus) occurs within a few hours after birth, anatomical closure may take several weeks. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Patency of the Ductus Arteriosus
- What is being tested?
- Patent Ductus Arteriosus in neonates
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2024to 30 Sep 2026
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Full-term and preterm neonates admitted to the aforementioned operational unit after birth, undergoing closure of the hsPDA (hemodynamically significant Patent Ductus Arteriosus) according to standard clinical practice.
Who may be able to join
- Neonates under 28 days of life
- Patients eligible for hsPDA closure treatment according to standard clinical practice
Who cannot join
- Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
- Neonates with pneumothorax
- Neonates with pulmonary hemorrhage
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, roma, 00168
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Fondazione Policlinico Universitario Agostino Gemelli IRCCS, +39 06/30154417, angela.paladini@policlinicogemelli.it
About this study
Official title: The Predictive Value of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants: an Observational Pilot Study
The diagnostic hypothesis is based on the evidence that, while the functional closure of the PDA (Patent Ductus Arteriosus) occurs within a few hours after birth, anatomical closure may take several weeks. The functional closure of the PDA can be extremely sensitive to variations in blood oxygen tension and the hemodynamic instability of preterm infants. Therefore, echocardiographic evaluation and ductal diameter at a single point in time (such as during PDA echocardiography) may not correlate with transductal blood flow. Assessing the variation in the amount of pulmonary interstitial fluid using LUS (lung ultrasound score) could be an early predictive parameter for the closure or non-closure of hsPDA (hemodynamically significant PDA).
- Conditions
- Patency of the Ductus Arteriosus
- Being tested
- Patent Ductus Arteriosus in neonates
- 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.
Patent Ductus Arteriosus in neonatesDiagnostic test
Neonates admitted to Neonatal care Unit after birth, undergoing hsPDA (hemodynamically significant Patent Ductus Arteriosus) closure according to standard clinical practice, will be included.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound score variability
To assess the changes, particularly any reduction in the lung ultrasound score (LUS), during the closure of the hemodynamically significant PDA, according to standard clinical practice. The LUS score can range from 0 to 12. Higher values correspond to a greater overflow of fluids in the lungs.
Measured: From enrollment to the end of treatment on average of 3 - 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start20 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patency of the Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paladini Angela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627374
- Sponsor's protocol ID
- 6973
- Acronym
- LUNG PDA
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants: an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06627374
- Acronym / sponsor ID
- LUNG PDA / 6973
- Conditions
- Patency of the Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Oct 2024 (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 diagnostic hypothesis is based on the evidence that, while the functional closure of the PDA (Patent Ductus Arteriosus) occurs within a few hours after birth, anatomical closure may take several weeks. The functional closure of the PDA can be extremely sensitive to variations in blood oxygen tension and the hemodynamic instability of preterm infants. Therefore, echocardiographic evaluation and ductal diameter at a single point in time (such as during PDA echocardiography) may not correlate with transductal blood flow. Assessing the variation in the amount of pulmonary interstitial fluid using LUS (lung ultrasound score) could be an early predictive parameter for the closure or non-closure of hsPDA (hemodynamically significant PDA).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Full-term and preterm neonates admitted to the aforementioned operational unit after birth, undergoing closure of the hsPDA (hemodynamically significant Patent Ductus Arteriosus) according to standard clinical practice.
Key inclusion criteria (2 listed)
- Neonates under 28 days of life
- Patients eligible for hsPDA closure treatment according to standard clinical practice
Key exclusion criteria (3 listed)
- Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
- Neonates with pneumothorax
- Neonates with pulmonary hemorrhage
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 |
|---|---|---|
| Patent Ductus Arteriosus in neonatesNeonates admitted to Neonatal care Unit after birth, undergoing hsPDA (hemodynamically significant Patent Ductus Arteriosus) closure according to standard clinical practice, will be included. | Diagnostic test | – |
Primary outcome
Lung ultrasound score variability
Time frame: From enrollment to the end of treatment on average of 3 - 15 days
To assess the changes, particularly any reduction in the lung ultrasound score (LUS), during the closure of the hemodynamically significant PDA, according to standard clinical practice. The LUS score can range from 0 to 12. Higher values correspond to a greater overflow of fluids in the lungs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patency of the Ductus Arteriosus, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Angela Paladini (+39 3272037468, angela.paladini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound score variability (time frame: From enrollment to the end of treatment on average of 3 - 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.