Actively Recruiting

Phase Not Applicable
Age: 0 - 1Month
All Genders
NCT06443515

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

80 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Respiratory Trends During Blood Transfusions in Newborns.

Who Can Participate

Age: 0 - 1Month
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns admitted to the hospital who need blood transfusions according to local practice or international guidelines
Not Eligible

You will not qualify if you...

  • Newborns with major malformations
  • Newborns receiving palliative care
  • Lack of informed consent

AI-Screening

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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

CONTACT

S

Stefano Nobile

CONTACT

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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Respiratory Trends During Blood Transfusions in Newborns. | DecenTrialz