← Eichor
Study identifier: NCT06443515 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Respiratory Trends During Blood Transfusions in Newborns.

Condition: Blood Transfusion Complication · Blood Transfusion Associated Adverse Reactions · Respiratory Complication  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhaseNA
Planned participants71
Who can joinAll sexes, N/A to 1 Month
Healthy volunteersNo

About this study

The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction. Most noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema). Although TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed. According to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used. Therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.

This description comes directly from the study's public registry record.

Talk to the study team

Stefano Nobile, MD, PhD, MSc  ·  +39 06 30151  ·  stefano.nobile@policlinicogemelli.it

Stefano Nobile  ·  stefano.nobile@policlinicogemelli.it

Always discuss trial participation with your own doctor first.

Locations (1)

Fondazione Policlinico Gemelli IRCCSRoma, ItalyRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06443515