Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants
- Conditions
- Patency of the Ductus Arteriosus
- Registration Number
- NCT06627374
- Brief 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. 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Neonates under 28 days of life
- Patients eligible for hsPDA closure treatment according to standard clinical practice
- Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
- Neonates with pneumothorax
- Neonates with pulmonary hemorrhage
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lung ultrasound score variability 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy