Respiratory Trends During Blood Transfusions in Newborns. (ARTE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Blood Transfusion Associated Adverse Reactions; Blood Transfusion Complication; Respiratory Morbidity; Respiratory Complication

Treatments: Diagnostic Test: lung ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06443515

6438 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 71 estimated patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

study group

Other group

Description:

All infants undergoing blood transfusions will be enrolled in the study

Treatment:

Diagnostic Test: lung ultrasound