Blood Warming in Preterm Infants to Decrease Hypothermia

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT05170633
Status
Recruiting
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Conditions

  • Blood Transfusion Complication
  • Hypothermia
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
24 Weeks - 32 Weeks
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Jan 1, 2022
Status verified
Dec 2024
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Standard care
    Standard care/Control group: The nurse will receive the PRBC transfusion from the Blood Bank. As standard care, there are no deliberate procedures for warming PRBC transfusions in this NICU. The syringe of blood may sit outside the incubator for some time and as such, will warm to the environmental ambient temperature while transfusing into the infant using a standard pump. The transfusion will be given over 4 hours, per the clinician's orders. The bedside nurse will document transfusion start and stop times, and route, on the study document at the bedside. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid.
  • Active Comparator: Intervention
    Intervention group: Once a nurse receives the PRBC from the Blood Bank, the nurse will obtain a specialized tubing and use a commercial PRBC warming device, the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) to deliver the PRBC transfusion to the infant. The unit contains highly responsive aluminum heating plates that distribute heat quickly, which responds to flow changes with even and consistent heat. The plate temperature is monitored 4 times per second and is accurate within 1°C (3M Healthcare, Oakdale, Minnesota). The Ranger blood warmer meets the American Association of Blood Bank (AABB) guidelines for warming blood. All times and information associated with the PRBC transfusion will be recorded on the bedside study document. The transfusion will be given over 4 hours, per the clinician's orders. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid.

Primary Outcome Measure

the occurrence of hypothermia [ Time Frame: 12 hours of the transfusion time ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kayla EverhartColumbiaSouth Carolina29208
Kayla Everhart, PhD
[email protected]
910-471-5958
Victor N Iskersky, MD
[email protected]
803-434-2912

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