Clinical trial NCT06443515: Respiratory Trends During Blood Transfusions in Newborns.
Official title: Evaluation of Respiratory Trends During Blood Transfusions in Newborns.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Transfusion Complication
Blood Transfusion Associated Adverse Reactions
Respiratory Complication
Respiratory Morbidity
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 71
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Primary outcomes:
measure: Changes in lung ultrasound score (LUS score) before and after transfusions
timeFrame: within 6 hours before and after the transfusion
measure: Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions
timeFrame: within 6 hours before and after the transfusion
Secondary outcomes:
measure: Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilation
timeFrame: within 6 hours before and after the transfusion
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Stefano Nobile, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: