Respiratory Trends During Blood Transfusions in Newborns. (ARTE)

Evaluation of Respiratory Trends During Blood Transfusions in Newborns.

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Complication; Respiratory Morbidity; Blood Transfusion Complication; Blood Transfusion Associated Adverse Reactions
• Intervention / Treatment: Diagnostic test: lung ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Nobile, MD, PhD, MSc; Phone Number: +39 06 30151; Email: stefano.nobile@policlinicogemelli.it
• Study Contact Backup: Name: Stefano Nobile; Email: stefano.nobile@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Gemelli IRCCS
    • Contact: Stefano Nobile, MD, PhD, MSc; Phone Number: +390630151; Email: stefano.nobile@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study group; All infants undergoing blood transfusions will be enrolled in the study	Diagnostic test: lung ultrasound; Lung ultrasound examinations will be performed within 6 hours before and after blood transfusion to assess interstitial-alveolar fluid retention and calculate a LUS score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lung ultrasound score (LUS score) before and after transfusions	LUS score according to previous publications (Brat et al., 2015) will be calculated	within 6 hours before and after the transfusion
Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions	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	within 6 hours before and after the transfusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Stefano Nobile, MD, PhD, MSc, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: 6438 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No