Actively Recruiting
Blood Warming in Preterm Infants to Decrease Hypothermia
Led by University of South Carolina · Updated on 2024-12-11
140
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of South Carolina
Lead Sponsor
T
The Gerber Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blood Warming in Preterm Infants to Decrease Hypothermia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born at PRISMA Health Richland hospital
- Less than 32 weeks gestational age by obstetrical dating
- Admitted to the neonatal intensive care unit
- Receiving one packed red blood cell transfusion within the first month of life
You will not qualify if you...
- Infants with neurological anatomical abnormalities
- Infants with major brain hemorrhage (Grade III or IV)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kayla Everhart
Columbia, South Carolina, United States, 29208
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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