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NCT Number: NCT06443515

Respiratory Trends During Blood Transfusions in Newborns.

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.

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Key information

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

Stefano Nobile, MD, PhD, MSc

CONTACT

[email protected]

+390630151

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: within 6 hours before and after the transfusion

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

  2. 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

    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

Secondary outcomes

  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

    MAP as displayed by ventilators will be recorded as median values

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Nobile

CONTACT

[email protected]

Stefano Nobile, MD, PhD, MSc

CONTACT

[email protected]

+39 06 30151

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluation of Respiratory Trends During Blood Transfusions in Newborns.

Acronym: ARTE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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