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

NCT06627374 | Recruiting

• 1 other identifier: 6973
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Patency of the Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Neonates under 28 days of life
• Patients eligible for hsPDA closure treatment according to standard clinical practice

You may not qualify if:

• Neonates with congenital heart diseases (except for PDA and patent foramen ovale)
• Neonates with pneumothorax
• Neonates with pulmonary hemorrhage

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Angela Paladini

CONTACT

+39 3272037468; angela.paladini@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 4, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)