NCT06443515 Respiratory Trends During Blood Transfusions in Newborns.
| NCT ID | NCT06443515 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Blood Transfusion Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 71 participants in total. It began in 2024-07-01 with a primary completion date of 2025-12-31.
⚠ 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 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.
Eligibility 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
Contact & Investigator
Stefano Nobile, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06443515 clinical trial?
This trial is open to participants of all sexes, up to 1 Month, studying Blood Transfusion Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06443515 currently recruiting?
Yes, NCT06443515 is actively recruiting participants. Contact the research team at stefano.nobile@policlinicogemelli.it for enrollment information.
Where is the NCT06443515 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06443515 clinical trial?
NCT06443515 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Stefano Nobile, MD, PhD, MSc at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 71 participants.