NCT06627374 Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants
| NCT ID | NCT06627374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Patency of the Ductus Arteriosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-20 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-09-20 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06627374 clinical trial?
This trial is open to participants of all sexes, up to 28 Days, studying Patency of the Ductus Arteriosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627374 currently recruiting?
Yes, NCT06627374 is actively recruiting participants. Contact the research team at angela.paladini@policlinicogemelli.it for enrollment information.
Where is the NCT06627374 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06627374 clinical trial?
NCT06627374 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 50 participants.