Respiratory Trends During Blood Transfusions in Newborns.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lung ultrasound.
- Who it may be relevant to
- Registry conditions: Blood Transfusion Complication, Blood Transfusion Associated Adverse Reactions, Respiratory Complication, Respiratory Morbidity. Basic parameters: up to 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Respiratory Trends During Blood Transfusions in Newborns.
Overview
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 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
Primary outcome measures
- Changes in lung ultrasound score (LUS score) before and after transfusions [Time frame: within 6 hours before and after the transfusion]
- Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions [Time frame: within 6 hours before and after the transfusion]
Secondary outcome measures (1)
- Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilation [Time frame: within 6 hours before and after the transfusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Fondazione Policlinico Gemelli IRCCS — Roma
Identifiers
NCT: NCT06443515 · 6438