Blood Warming in Preterm Infants to Decrease Hypothermia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-32
SponsorUniversity of South Carolina

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the occurrence of hypothermia

the occurrence of hypothermia, defined as a mean central temperature \< 36.5°C, in the intervention versus control groups

Time frame
12 hours of the transfusion time
2

hypothermia after completion

comparison of mean central body temperatures for the two groups, from temperatures measured after the pack red blood cell (PRBC) transfusion is complete.

Time frame
1 hour post-transfusion

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of South Carolina

Lead sponsor

The Gerber Foundation

Collaborator

Prisma Health-Midlands

Collaborator