Blood Warming in Preterm Infants to Decrease Hypothermia
Recruiting now · Not applicable
Conditions studied: Preterm Birth, Blood Transfusion Complication, Hypothermia
In brief
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion. Researchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (\<36.5°C) in very preterm infants during PRBC transfusions. Process: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit. Outcomes: Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures \<36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care. Hypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide.
Key facts
- Study ID
- NCT05170633
- Run by
- University of South Carolina
- People needed
- 140
- Starts
- 2022-01-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2024-12-11
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Any infant born at PRISMA Health Richland hospital
- less than 32 weeks gestational age by obstetrical dating as indicated in the electronic medical chart
- admitted to the neonatal intensive care unit receiving one PRBC transfusion within the first month of life.
You may not qualify if…
- Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.
Where it is running
- Kayla Everhart — Columbia, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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