INSPIRE Study v1.1
Research type
Research Study
Full title
INSPIRE-study (International Neonatal tranSfusion PoInt pREvalence)
IRAS ID
324674
Contact name
C Roehr
Contact email
Sponsor organisation
Leiden University Medical Center
Clinicaltrials.gov Identifier
326992, Consent Advisory Group Application
Duration of Study in the UK
0 years, 5 months, 2 days
Research summary
Neonates are a cohort of patients who receive a great deal of blood product transfuisons. However, there is a paucity of evidence centred on blood product transfusion in neonatal practice. Two recently published randomized controlled trials indicated no benefit in long-term outcomes when using high transfusion thresholds for red blood cell transfusion in neonates. Similarly, another randomised control trial, comparing a high and low platelet transfusion threshold, reported that higher platelet transfusion thresholds can result in harm. At present there is no unifying consensus on transfusion thresholds for neonates and no international neonatal transfusion guidelines adopted within Europe. This means there is an ongoing great deal of variation in practices among neonatal units across the continent.
Hence, this point prevalence study will provide a clear picture of current neonatal transfusion practices across Europe, which can be used as a starting point to inform future randomised control trials, develop evidence based transfusion guidelines and encourage adherence to this and ultimately improve practice.
The aim of the study is: "To describe the prevalence, indications, adverse effects, and component specifications of RBC, platelet, and plasma transfusions in preterm neonates. Additionally, to describe the use of local or national guidelines and the evidence-basedness of transfusion practices in preterm neonates."
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0108
Date of REC Opinion
20 Apr 2023
REC opinion
Favourable Opinion