Preterm infants, Anemia, Red blood cell transfusion, Transfusion threshold, Neurodevelopmental outcome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - A gestational age < 32 weeks - Age between 0 and 7 days - Written informed consent by legal representative(s)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Chromosomal abnormality (e.g. trisomy 13, 18, 21) - Perinatal asphyxia resulting in Apgar score (AS) grade 2 according to Papile, prior to inclusion - Alloimmune hemolytic disease, sickle-cell disease or thalassemia - Any received RBC transfusions prior to inclusion - Inability to understand Dutch by the parents - Parents expressing strong philosophical or religious objections to transfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the neurological outcome at the age of three months post term, based on the motor optimality score (MOS) of the quality of General Movements (GMs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be the incidence of in-hospital mortality and morbidities NEC, BPD, ROP, and deterioration of IVH assessed at 3 months post term age. Urinary I-FABP levels will be measured to determine intestinal cell damage as early marker for NEC. Cerebral regional tissue oxygen saturation and the total amount of RBC transfusions during the study period of 4 weeks will be recorded. | — |
Contacts
UMCG