NCT05170633 Blood Warming in Preterm Infants to Decrease Hypothermia
| NCT ID | NCT05170633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Carolina |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2022-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Frequently Asked Questions
Who can join the NCT05170633 clinical trial?
This trial is open to participants of all sexes, aged 24 Weeks or older, up to 32 Weeks, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05170633 currently recruiting?
Yes, NCT05170633 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of South Carolina to inquire about joining.
Where is the NCT05170633 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT05170633 clinical trial?
NCT05170633 is sponsored by University of South Carolina. The trial plans to enroll 140 participants.