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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Patency of the Ductus Arteriosus

Treatments

Diagnostic Test: Patent Ductus Arteriosus in neonates

Study type

Observational

Funder types

Other

Identifiers

NCT06627374
6973 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

50 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No 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

Trial contacts and locations

1

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Central trial contact

Angela Paladini

Data sourced from clinicaltrials.gov

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