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

Recruiting now

Conditions studied: Patency of the Ductus Arteriosus

In brief

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).

Key facts

Study ID

NCT06627374

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

50

Starts

2024-09-20

Expected to finish

2026-09-30

Last updated by the study team

2024-10-15

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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