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Respiratory Trends During Blood Transfusions in Newborns.

Evaluation of Respiratory Trends During Blood Transfusions in Newborns.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06443515
Acronym
ARTE
Enrollment
71
Registered
2024-06-05
Start date
2024-07-01
Completion date
2026-01-15
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTlung 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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in lung ultrasound score (LUS score) before and after transfusionswithin 6 hours before and after the transfusionLUS score according to previous publications (Brat et al., 2015) will be calculated
Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusionswithin 6 hours before and after the transfusionnon-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

Secondary

MeasureTime frameDescription
Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilationwithin 6 hours before and after the transfusionMAP as displayed by ventilators will be recorded as median values

Countries

Italy

Contacts

Primary ContactStefano Nobile, MD, PhD, MSc
stefano.nobile@policlinicogemelli.it+39 06 30151
Backup ContactStefano Nobile
stefano.nobile@policlinicogemelli.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026