Respiratory Trends During Blood Transfusions in Newborns.

NCT06443515 | Recruiting

• 1 other identifier: 6438
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

study group

OTHER

All infants undergoing blood transfusions will be enrolled in the study

Diagnostic Test: lung ultrasound

Interventions

lung ultrasound DIAGNOSTIC_TEST

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

study group

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• admitted newborns requiring blood transfusions as per local practice and/or international guidelines

You may not qualify if:

• newborns with major malformations
• need for palliative care
• lack of informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Stefano Nobile, MD, PhD, MSc

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nobile, MD, PhD, MSc

CONTACT

+39 06 30151; stefano.nobile@policlinicogemelli.it

Stefano Nobile

CONTACT

stefano.nobile@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 15, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)