Respiratory Trends During Blood Transfusions in Newborns.

Respiratory Complication Clinical Trial

— ARTE  

Official title:

Evaluation of Respiratory Trends During Blood Transfusions in Newborns.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443515
• Other study ID #: 6438
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 7, 2024
• Est. completion date: January 15, 2026

Study information

• Verified date: May 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefano Nobile, MD, PhD, MSc
• Phone: +39 06 30151
• Email: stefano.nobile[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: January 15, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion Associated Adverse Reactions
• Blood Transfusion Complication
• Respiratory Complication
• Respiratory Morbidity
• Transfusion Reaction

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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