Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT05170633
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2021-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Warming in Preterm Infants to Decrease Hypothermia
Sponsor:
University of South Carolina
Organization:
Study Overview
Official Title:
Evaluation of a Blood Warming Device for Packed Red Blood Cell Transfusions to Decrease Hypothermia in Very Preterm Infants
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This randomized controlled trial aims to improve treatment protocols during packed red blood cell (PRBC) transfusions in very preterm infants by using a blood warming device, Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) with the main goal of preventing hypothermic body temperatures (\<36.5°C) in very preterm infants during packed red blood cell (PRBC) transfusions. Very preterm infants, born less than 32 weeks gestational age, experience hypothermia after birth and throughout their hospitalization in the neonatal intensive care unit due to inefficient heat production and environmental heat loss. Hypothermia in preterm infants causes increased morbidity and mortality and prevention of hypothermic body temperature is the focus of many interventions used in neonatal care. Most research has focused on prevention of hypothermia after birth through stabilization. Importantly, critical high-tech incubators are used to care for preterm infants throughout their hospitalization, to prevent heat loss and maintain a thermoneutral environment.
One area that has been overlooked is the warming of PRBC transfusions that are given to preterm infants to replace blood volume depleted due to frequent testing to guide clinicians in their medical management. Because these small blood transfusions are sent from the blood bank freezer, infusion of this life-saving blood into a very preterm infant often results in hypothermic body temperatures. We completed a national survey of blood transfusion practices in neonatal intensive care units which revealed that standard care across the nation does not dictate the use of a warming device for these small PRBC transfusions; although, few are beginning to use warming devices. Because hypothermia in preterm infants leads to increased morbidity and mortality, it is crucial to protect very preterm infants from heat loss from infusing cold blood. A study completed in 2020 performed simulated PRBC transfusions, using a commercial blood warmer and revealed that blood products can be delivered at near-physiologic temperatures with no detected damage to the cells however, the study was not designed to examine the impact of a blood warmer on hypothermia in very preterm infants. Therefore, the primary aim of this study is to test the effect of the Ranger blood warmer on the incidence of post PRBC transfusion hypothermia in very preterm infants.
One area that has been overlooked is the warming of PRBC transfusions that are given to preterm infants to replace blood volume depleted due to frequent testing to guide clinicians in their medical management. Because these small blood transfusions are sent from the blood bank freezer, infusion of this life-saving blood into a very preterm infant often results in hypothermic body temperatures. We completed a national survey of blood transfusion practices in neonatal intensive care units which revealed that standard care across the nation does not dictate the use of a warming device for these small PRBC transfusions; although, few are beginning to use warming devices. Because hypothermia in preterm infants leads to increased morbidity and mortality, it is crucial to protect very preterm infants from heat loss from infusing cold blood. A study completed in 2020 performed simulated PRBC transfusions, using a commercial blood warmer and revealed that blood products can be delivered at near-physiologic temperatures with no detected damage to the cells however, the study was not designed to examine the impact of a blood warmer on hypothermia in very preterm infants. Therefore, the primary aim of this study is to test the effect of the Ranger blood warmer on the incidence of post PRBC transfusion hypothermia in very preterm infants.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: