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RECRUITING
NCT06627374

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

Any - 28 Days

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-09-20

Completion Date

2026-09-30

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Patent 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.

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, roma, Italy