Evaluating a blood warming device for packed red blood cell transfusions to decrease hypothermia in very preterm infants: A randomised control trial protocol.

BACKGROUND

This protocol describes a study to test a commercial blood warming device in warming blood transfusions to prevent hypothermia associated with packed red blood cell (PRBC) transfusions in very preterm infants.

OBJECTIVES

Very preterm infants receiving blood transfusions warmed by a commercial blood warmer will have less central body hypothermia post transfusion (abdominal temperatures <36.5°C) and/or a higher mean abdominal temperature for the hour after the transfusion is complete compared to those receiving blood transfusions by standard of care. This trial has been registered with Clinicaltrials.gov (trial number NCT05170633).

METHODS

In this trial, which is funded by The Gerber Foundation and adhered to the SPIRIT2013 checklist, 140 very preterm infants with an order to receive PRBCs will be randomised into a standard of care group to receive one PRBC transfusion over 3 h with blood in a syringe at room temperature or into the intervention group to receive one PRBC transfusion over 3 h using a Hotline® Blood and Fluid Warmer. Abdominal skin temperatures will be measured every minute through a blood transfusion using a skin thermistor and datalogger.

DATA ANALYSIS: Descriptive statistics will be computed for each group to compare demographics and all infant pre-, during, and post-transfusion body temperatures. A student t-test will be used to compare the groups on mean post-transfusion temperatures as a primary outcome variable. To examine thermal change over time between the two groups, linear mixed models with a random intercept will be utilised.

RESULTS

This trial began in January 2022, in a South Carolina neonatal intensive care unit and is ongoing.

DISCUSSION: This RCT will determine if warming PRBC transfusions will prevent hypothermia in preterm infants during and after blood transfusions. Results from this trial will be used to design national standards for blood transfusions in preterm infants to decrease morbidity and mortality.