Actively Recruiting
Led by University of South Carolina · Updated on 2024-12-11
140
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of South Carolina
Lead Sponsor
T
The Gerber Foundation
Collaborating Sponsor
Researchers are studying very preterm infants born before 32 weeks gestational age who often experience hypothermia and anemia during their stay in the neonatal intensive care unit. This trial evaluates the use of a commercial blood warming device to prevent low body temperatures (below 36.56C) during packed red blood cell (PRBC) transfusions, which are commonly needed to treat anemia in these infants. The study aims to reduce hypothermia-related complications by improving transfusion practices. The trial compares two groups: one receives standard care with PRBC transfusions given without deliberate warming, and the other group receives transfusions warmed using the Ranger blood warmer device. The device uses aluminum heating plates to quickly and evenly warm blood to near body temperature, following blood bank guidelines. Transfusions last about 4 hours, and all details including timing are recorded by nurses. Participants will be closely monitored for body temperature during and after the transfusion, especially focusing on the occurrence of hypothermia within 12 hours and 1 hour after transfusion ends. Temperature data are collected for 24 hours after transfusion to ensure accuracy. The study measures how well the warming device maintains normal body temperature to improve care for very preterm infants at risk of hypothermia during blood transfusions.
CONDITIONS
Blood Warming in Preterm Infants to Decrease Hypothermia
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 hours
Participants receive a packed red blood cell transfusion either with standard care or using the Ranger blood warming device to prevent hypothermia.
1 transfusion visit (in-person)
Duration - 24 hours
Participants are monitored for 24 hours after the transfusion to verify temperature data and check for hypothermia.
Monitoring during and after transfusion without additional visits
Total: 1 location
1
Kayla Everhart
Columbia, South Carolina, United States, 29208
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Kayla C Everhart, Michael D Wirth, Victor N Iskersky...
https://pubmed.ncbi.nlm.nih.gov/40371767