Using thoracic ultrasound to monitor closure of a heart condition 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
This study is testing if lung ultrasound can help doctors see if a heart condition called patent ductus arteriosus is closing in premature infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | N/A to 28 Days |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, roma) |
| Trial ID | NCT06627374 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the use of thoracic ultrasound to assess the closure of hemodynamically significant patent ductus arteriosus (hsPDA) in premature infants. It aims to determine if lung ultrasound scores can serve as an early predictive parameter for the closure of hsPDA, given that functional closure occurs shortly after birth while anatomical closure may take longer. The study will evaluate the relationship between pulmonary interstitial fluid and the closure of the ductus arteriosus in neonates under 28 days of life who are eligible for treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates under 28 days of life who are eligible for treatment of hsPDA according to standard clinical practice.
Not a fit: Patients with congenital heart diseases (other than PDA and patent foramen ovale), pneumothorax, or pulmonary hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and management of patent ductus arteriosus in premature infants, potentially reducing complications.
How similar studies have performed: While the use of ultrasound in monitoring cardiac conditions is established, this specific approach to assessing hsPDA closure is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma, roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, roma, Italy (Recruiting)
Study contacts
- Study coordinator: Angela Paladini
- Email: angela.paladini@policlinicogemelli.it
- Phone: +39 3272037468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.