HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by University of South Carolina · Updated on 2024-12-11
140
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying very preterm infants born before 32 weeks gestational age who often experience hypothermia and anemia during their stay in the neonatal intensive care unit. This trial evaluates the use of a commercial blood warming device to prevent low body temperatures below 36.56C during packed red blood cell PRBC transfusions, which are commonly needed to treat anemia in these infants. The study aims to reduce hypothermia-related complications by improving transfusion practices. The trial compares two groups one receives standard care with PRBC transfusions given without deliberate warming, and the other group receives transfusions warmed using the Ranger blood warmer device. The device uses aluminum heating plates to quickly and evenly warm blood to near body temperature, following blood bank guidelines. Transfusions last about 4 hours, and all details including timing are recorded by nurses. Participants will be closely monitored for body temperature during and after the transfusion, especially focusing on the occurrence of hypothermia within 12 hours and 1 hour after transfusion ends. Temperature data are collected for 24 hours after transfusion to ensure accuracy. The study measures how well the warming device maintains normal body temperature to improve care for very preterm infants at risk of hypothermia during blood transfusions.
CONDITIONS
Blood Warming in Preterm Infants to Decrease Hypothermia
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of South Carolina
Lead Sponsor
The Gerber Foundation
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Ranger blood warmer device | Standard care (no blood warming device) |
|---|---|---|
| What it is | A blood warming device (Ranger blood warmer, 3M Healthcare) used inline during packed red blood cell transfusion in preterm infants to warm the blood as it is administered. | Standard blood transfusion practice in this NICU population, which does not use a dedicated inline blood warming device during transfusion. |
| Role in the trial | Investigational intervention arm: infants receive blood transfusion through the Ranger blood warmer device. | Comparator arm: infants receive standard blood transfusion care with no additional warming device. |
| Primary use | To evaluate whether inline blood warming reduces the risk of hypothermia after packed red blood cell transfusion in very preterm infants. | Represents the usual practice to understand how often hypothermia occurs after standard transfusion procedure in preterm infants. |
| How it is given or performed | Blood is transfused through the Ranger blood warmer device to achieve temperature-controlled delivery during the transfusion session. | Blood is administered using the standard procedure without any additional warming device. |
| Evidence status | Evidence for outcomes with this device comes from ongoing clinical investigation; no published patient outcome results are available as of the trial protocol publication. | Clinical outcomes for standard transfusion care in preterm infants are being measured for comparison in this ongoing trial; no additional published outcome data are provided. |
| Important limitations | Results to determine whether the blood warming device decreases hypothermia in this population are not yet available; safety and efficacy have not been established for this specific NICU use. | Direct comparison data regarding risk of hypothermia or other complications during blood transfusion without warming remain limited and pending completion of this trial. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 hours
Participants receive a packed red blood cell transfusion either with standard care or using the Ranger blood warming device to prevent hypothermia.
1 transfusion visit (in-person)
Duration - 24 hours
Participants are monitored for 24 hours after the transfusion to verify temperature data and check for hypothermia.
Monitoring during and after transfusion without additional visits
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Kayla C Everhart, Michael D Wirth, Victor N Iskersky...
https://pubmed.ncbi.nlm.nih.gov/40371767/University of South Carolina
Lead Sponsor
The Gerber Foundation
Collaborating Sponsor
