Using a blood warmer to prevent hypothermia in preterm infants during blood transfusions
Evaluation of a Blood Warming Device for Packed Red Blood Cell Transfusions to Decrease Hypothermia in Very Preterm Infants
NA · University of South Carolina · NCT05170633
This study is testing if using a blood warmer during blood transfusions can help very preterm infants stay warm and avoid hypothermia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 24 Weeks to 32 Weeks |
| Sex | All |
| Sponsor | University of South Carolina (other) |
| Locations | 1 site (Columbia, South Carolina) |
| Trial ID | NCT05170633 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve the care of very preterm infants by using a Ranger blood warmer during packed red blood cell (PRBC) transfusions to prevent hypothermia. The study will involve 140 infants born at less than 32 weeks gestational age who are admitted to the neonatal intensive care unit and require a PRBC transfusion within their first month of life. Researchers will compare the body temperatures of infants receiving warmed blood to those receiving standard transfusions to assess the effectiveness of this intervention in reducing hypothermia. The trial is based on previous findings that highlight the risk of hypothermia during blood transfusions in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at less than 32 weeks gestational age who are admitted to the neonatal intensive care unit and require a PRBC transfusion within their first month of life.
Not a fit: Patients with neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV) may not benefit from this study due to their compromised thermal control.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hypothermia in very preterm infants during blood transfusions, potentially improving their overall health outcomes.
How similar studies have performed: While there has been limited research specifically on warming PRBC transfusions in preterm infants, the approach of preventing hypothermia in neonatal care has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.
Where this trial is running
Columbia, South Carolina
- Kayla Everhart — Columbia, South Carolina, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Birth, Blood Transfusion Complication, Hypothermia