Respiratory Trends During Blood Transfusions in Newborns.

Not Applicable

Not yet recruiting

• Conditions: Respiratory Morbidity; Blood Transfusion Complication; Blood Transfusion Associated Adverse Reactions; Respiratory Complication
• Interventions: Diagnostic Test: lung ultrasound

• Registration Number: NCT06443515
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05
• Study Start: 2024-06-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	lung ultrasound	All infants undergoing blood transfusions will be enrolled in the study

Primary Outcome Measures

Name	Time	Method
Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions	within 6 hours before and after the transfusion	non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) will be calculated from clinical charts: data validated by caregivers (primary nurses) will be extracted from the electronic charts to calculate this ratio
Changes in lung ultrasound score (LUS score) before and after transfusions	within 6 hours before and after the transfusion	LUS score according to previous publications (Brat et al., 2015) will be calculated

Secondary Outcome Measures

Name	Time	Method
Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilation	within 6 hours before and after the transfusion	MAP as displayed by ventilators will be recorded as median values

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy