Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants (LUNG PDA)

October 9, 2024 updated by: Paladini Angela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

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 Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs
        • Contact:
          • Fondazione Policlinico Universitario Agostino Gemelli IRCCS Fondazione Policlinico Universitario Agostino Gemelli IRCCS
          • Phone Number: +39 06/30154417
          • Email: angela.paladini@policlinicogemelli.it

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Neonates under 28 days of life
  • Patients eligible for hsPDA closure treatment according to standard clinical practice

Exclusion Criteria:

  • Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
  • Neonates with pneumothorax
  • Neonates with pulmonary hemorrhage

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
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.
From enrollment to the end of treatment on average of 3 - 15 days

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 (Actual)

September 20, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6973 (FHCRC IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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