Respiratory Trends During Blood Transfusions in Newborns.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

newborns with major malformations

need for palliative care

lack of informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

71 Participants
are divided into 1 treatment group
Group A: study groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Changes in lung ultrasound score (LUS score) before and after transfusions

LUS score according to previous publications (Brat et al., 2015) will be calculated

Time frame
within 6 hours before and after the transfusion
2

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

Time frame
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

MAP as displayed by ventilators will be recorded as median values

Time frame
within 6 hours before and after the transfusion

Other outcomes

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