Monitoring respiratory trends in newborns receiving blood transfusions
Evaluation of Respiratory Trends During Blood Transfusions in Newborns.
This study is testing if using lung ultrasound can help doctors spot breathing problems in newborns receiving blood transfusions to keep them safer and healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 71 (estimated) |
| Ages | N/A to 1 Month |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06443515 on ClinicalTrials.gov |
What this trial studies
This study investigates the respiratory complications associated with blood transfusions in newborns, focusing on the prevalence and types of transfusion reactions such as TACO and TRALI. It employs lung ultrasound as a non-invasive method to monitor respiratory trends during transfusions. The aim is to identify early signs of adverse reactions to improve patient safety and outcomes. By understanding these trends, the study seeks to enhance clinical practices surrounding blood transfusions in neonatal care.
Who should consider this trial
Good fit: Ideal candidates for this study are admitted newborns who require blood transfusions according to established guidelines.
Not a fit: Newborns with major malformations, those in need of palliative care, or those whose guardians do not provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of respiratory complications in newborns undergoing blood transfusions.
How similar studies have performed: While the specific approach of using lung ultrasound in this context may be novel, previous studies have indicated the importance of monitoring transfusion reactions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * admitted newborns requiring blood transfusions as per local practice and/or international guidelines Exclusion Criteria: * newborns with major malformations * need for palliative care * lack of informed consent
Where this trial is running
Roma
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Nobile, MD, PhD, MSc — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Stefano Nobile, MD, PhD, MSc
- Email: stefano.nobile@policlinicogemelli.it
- Phone: +39 06 30151
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.