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NCT05170633 · ClinicalTrials.gov registry record · NA
Blood Warming in Preterm Infants to Decrease Hypothermia
A NA study of Preterm Birth and Hypothermia, sponsored by University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05170633 is a NA study of Preterm Birth and Hypothermia that is actively recruiting participants, run by University of South Carolina. The registered enrollment target is 140 participants, below the 4,626-participant average among 37 other Preterm Birth trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05170633, a NA study of Preterm Birth and Hypothermia, is actively recruiting participants, sponsored by University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
Study Locations (1)
South Carolina
- Kayla Everhart - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05170633
The ClinicalTrials.gov registry entry for NCT05170633 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,626-participant average among 37 other Preterm Birth trials with a reported enrollment target (97% lower). The listed sponsor is University of South Carolina, which has 157 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) is the first listed.
NCT05170633 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT05170633 about?
NCT05170633 is a clinical study titled "Blood Warming in Preterm Infants to Decrease Hypothermia". 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 Th...
What is the current status of trial NCT05170633?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2022-01-01. Estimated completion is 2026-01-01.
What conditions does trial NCT05170633 study?
This clinical trial studies the following conditions: Preterm Birth, Hypothermia, Blood Transfusion Complication.
What interventions are being tested in trial NCT05170633?
The interventions under investigation include: Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) (DEVICE).
Who is sponsoring clinical trial NCT05170633?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05170633 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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