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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patent Ductus Arteriosus in neonates | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment on average of 3 - 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Paladini | Contact | +39 3272037468 | angela.paladini@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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