RecruitingNot ApplicableNCT05170633

Blood Warming in Preterm Infants to Decrease Hypothermia

Evaluation of a Blood Warming Device for Packed Red Blood Cell Transfusions to Decrease Hypothermia in Very Preterm Infants


Sponsor

University of South Carolina

Enrollment

140 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 24 WeeksMax Age: 32 Weeks

Plain Language Summary

Simplified for easier understanding

This study is testing whether warming blood before giving it to premature babies as a transfusion helps prevent them from getting too cold (hypothermia). Very premature babies have trouble regulating their body temperature, and cold blood transfusions may make this worse. Researchers are studying whether blood warming devices make a difference. You may be eligible if: - Your baby was born before 32 weeks of pregnancy - Your baby was born at PRISMA Health Richland hospital - Your baby is in the NICU and needs a red blood cell (PRBC) transfusion within the first month of life You may NOT be eligible if: - Your baby has significant brain damage (Grade III or IV brain hemorrhage) - Your baby has neurological abnormalities that affect temperature control Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERanger blood warmer (3M Healthcare, Oakdale, Minnesota)

70 random infant will receive the packed red blood cell transfusion with the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)


Locations(1)

Kayla Everhart

Columbia, South Carolina, United States

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NCT05170633


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