Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold

Neonatal anemia is common in preterm infants. During their stay in the neonatal intensive care unit, most of these high-risk infants receive at least one red blood cell (RBC) transfusion. The lack of knowledge on the balance of potential benefits and risk of RBC transfusion for anemic preterm infants, have led to controversies about the optimal threshold for RBC transfusion for this population.

We intend to conduct a randomized controlled trial, comparing two treatment strategies for RBC transfusion in preterm infants: We will compare a newly developed strategy for treatment of preterm anemia with the current treatment strategy. In the new strategy, transfusion Hb thresholds will be lower by 1 mmol/l compared to the current thresholds, provided adequate cerebral oxygen saturation values are met.

Our primary objective is to test our hypothesis that a newly developed strategy with lower Hb thresholds for RBC transfusion than the current ones, provided adequate cerebral oxygen saturation values are met, will lead to a better neurological outcome in preterm infants at three monts post-term.

The duration of the study will be from signed informed consent (after admission to the NICU) until three months post-term. The intervention period at the NICU will be for a maximum of four weeks. During the study period the infants will have several non-invasive measurements.

The intervention strategy group will not receive an RBC transfusion (15-20 ml/kg leukocyte-reduced erythrocytes) in case of an Hb threshold which is 1.0 mmol/l lower than current guidelines, i.e. at an Hb threshold of 7.0 mmol/L or 6.0 mmol/L depending on ventilatory support, unless cerebral regional tissue oxygen saturation is lower than 72% for at least 30 consecutive minutes during the first four weeks after birth, or until discharge. The control group will be treated according to the current strategy, following the current clinical NICU guidelines with the threshold for RBC transfusion: Hb < 8.0 mmol/L if the infant is ventilated, and Hb < 7.0 mmol/L if not.