Actively Recruiting

Phase Not Applicable
Age: 0 - 1Month
All Genders
ID06443515

Evaluation of Respiratory Trends During Blood Transfusions in Newborns

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-24

71

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on newborn infants who require blood transfusions, aiming to study how their respiratory condition changes during these transfusions. The trial particularly examines complications like transfusion-associated cardiac overload (TACO) and transfusion-related acute lung injury (TRALI), which can affect the lungs and breathing. The study is important because respiratory transfusion reactions in newborns occur in about 8% of cases, especially in those with low birth weight and gestational age, but clear diagnostic criteria are lacking. Participants will undergo lung ultrasound examinations within six hours before and after their blood transfusions to detect fluid retention in the lungs and calculate a lung ultrasound score (LUS score). Oxygen saturation and fraction of inspired oxygen (SFR) levels will also be measured in this timeframe. For infants on respiratory support like nasal continuous positive airway pressure (nCPAP) or mechanical ventilation, ventilatory parameters such as mean airway pressure will be monitored before and after transfusions. Throughout the study, infants admitted for blood transfusions will be closely observed with these assessments to track any respiratory changes. Researchers will analyze lung ultrasound results, oxygen levels, and ventilation measures to identify respiratory trends and potential risk factors for worsening lung function related to transfusions. The study will continue until January 2026, with the primary outcomes focusing on changes in lung ultrasound scores and oxygenation within six hours around transfusions.

CONDITIONS

Brief Title

Respiratory Trends During Blood Transfusions in Newborns.

Who Can Participate

Age: 0 - 1Month
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted newborns requiring blood transfusions as per local practice and/or international guidelines
Not Eligible

You will not qualify if you...

  • Newborns with major malformations
  • Need for palliative care
  • Lack of informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Within hours of each blood transfusion

Participants undergo lung ultrasound examinations within 6 hours before and after blood transfusion to assess lung condition and calculate a lung ultrasound score.

2 visits per transfusion (before and after)

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

S

Stefano Nobile, MD, PhD, MSc

S

Stefano Nobile

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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