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NCT05170633

Blood Warming in Preterm Infants to Decrease Hypothermia

Recruiting now NA Last updated 11 December 2024
What this trial tests

NA trial testing Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) in Preterm Birth in 140 participants. Currently enrolling.

Timeline
1 January 2022
Primary endpoint
1 January 2026
1 January 2026

Quick facts

Lead sponsorUniversity of South Carolina
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment140
Start date1 January 2022
Primary completion1 January 2026
Estimated completion1 January 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Preterm Birth

Currently open trials in the same condition.

Other University of South Carolina trials

Trials by the same sponsor.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing