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NCT05170633
Blood Warming in Preterm Infants to Decrease Hypothermia
NA trial testing Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) in Preterm Birth in 140 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | University of South Carolina |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 140 |
| Start date | 1 January 2022 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
- Blood Transfusion Complication — all drugs for Blood Transfusion Complication →
- Hypothermia — all drugs for Hypothermia →
Sponsor
University of South Carolina
Who can join
Adults 24 Weeks to 32 Weeks, any sex, with Preterm Birth or Blood Transfusion Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluating a blood warming device for packed red blood cell transfusions to decrease hypothermia in very preterm infants: A randomised control trial protocol.
Everhart KC, Wirth MD, Iskersky VN, Dail RB. · · 2025 · cited 1× · PMID 40371767 · DOI 10.1111/tme.13143
Verify or expand the search:
- PubMed search for NCT05170633
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05170633 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Carolina
- Last refreshed: 11 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05170633.
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