Actively Recruiting
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
On this page
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
Eligibility Criteria
You may qualify if you...
- Newborns admitted to the hospital who need blood transfusions according to local practice or international guidelines
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
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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