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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06627374

Acronym

LUNG PDA

Enrollment

Registered

2024-10-04

Start date

2024-09-20

Completion date

2026-09-30

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patency of the Ductus Arteriosus

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).

Interventions

DIAGNOSTIC_TESTPatent Ductus Arteriosus in neonates

Neonates admitted to Neonatal care Unit after birth, undergoing hsPDA (hemodynamically significant Patent Ductus Arteriosus) closure according to standard clinical practice, will be included.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactAngela Paladini

angela.paladini@policlinicogemelli.it+39 3272037468

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026