Blood Warming for Preterm Infants to Reduce Hypothermia

This study is looking at whether using a special device called the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) can help prevent hypothermia (low body temperature) in very preterm infants during blood transfusions. Preterm infants, born before 32 weeks of pregnancy, often need blood transfusions and can easily get cold. Researchers want to see if warming the blood before it's given can keep their body temperature stable. The study plans to enroll 140 infants. Success for this study means fewer infants experiencing hypothermia within 12 hours of the transfusion, and also one hour after the transfusion is complete. The current status of this study is unclear.

Study design
This is an interventional study where 70 infants will randomly receive blood transfusions with the Ranger blood warmer. The study aims to enroll 140 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure hypothermia at 12 hours after the transfusion and at 1 hour post-transfusion.

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NCT05170633

Blood Warming in Preterm Infants to Decrease Hypothermia

Recruiting
NAAges 24–32InterventionalPrevention
University of South Carolina
~140 participants
Updated 2024-12-11 on ClinicalTrials.gov
What's tested:Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
the occurrence of hypothermia
Measured over 12 hours of the transfusion time
+1 more outcome measured
Preterm Birth
Blood Transfusion Complication
Hypothermia
1 sites across 1 states
South Carolina1

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Eligibility criteria

Inclusion

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.

Exclusion

Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.
  • the occurrence of hypothermia12 hours of the transfusion time

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

  • hypothermia after completion1 hour post-transfusion

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