Preterm BirthNCT05170633
Blood Warming in Preterm Infants to Decrease Hypothermia
A study testing Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) in people with Preterm Birth and Blood Transfusion Complication, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- What is being tested?
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kayla Everhart
Columbia, South Carolina, 29208
Kayla Everhart, PhD, 910-471-5958, everhakc@email.sc.edu
Victor N Iskersky, MD, 803-434-2912, Victor_Iskersky@MEDNAX.com
About this study
Official title: Evaluation of a Blood Warming Device for Packed Red Blood Cell Transfusions to Decrease Hypothermia in Very Preterm Infants
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.
Read more
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.
Read the 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.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Being tested
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Medical subject headings
- Premature Birth, Transfusion Reaction, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)Device
70 random infant will receive the packed red blood cell transfusion with the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Standard care/Control group: The nurse will receive the PRBC transfusion from the Blood Bank. As standard care, there are no deliberate procedures for warming PRBC transfusions in this NICU. The syringe of blood may sit outside the incubator for some time and as such, will warm to the environmental ambient temperature while transfusing into the infant using a standard pump. The transfusion will be given over 4 hours, per the clinician's orders. The bedside nurse will document transfusion start and stop times, and route, on the study document at the bedside. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid. |
| Intervention | Active comparator | Intervention group: Once a nurse receives the PRBC from the Blood Bank, the nurse will
obtain a specialized tubing and use a commercial PRBC warming device, the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) to deliver the PRBC transfusion to the infant. The unit contains highly responsive aluminum heating plates that distribute heat quickly, which
responds to flow changes with even and consistent heat. The plate temperature is monitored 4 times per second and is accurate within 1°C (3M Healthcare, Oakdale, Minnesota). The Ranger blood warmer meets the American Association of Blood Bank (AABB) guidelines for warming blood. All times and information associated with the PRBC transfusion will be recorded on the bedside study document. The transfusion will be given over 4 hours, per the clinician's orders. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid. Receives: Device: Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of hypothermia
the occurrence of hypothermia, defined as a mean central temperature < 36.5°C, in the intervention versus control groups
Measured: 12 hours of the transfusion time
hypothermia after completion
comparison of mean central body temperatures for the two groups, from temperatures measured after the pack red blood cell (PRBC) transfusion is complete.
Measured: 1 hour post-transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation, Prisma Health-Midlands
- Responsible party
- Principal investigator, Kayla Chavis Everhart, PhD, RN, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170633
- Sponsor's protocol ID
- 9040
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once Dr. Everhart receives temperatures for each study infant, these files will be stored in a study file on the UofSC server. These data are associated with unique study numbers and contain no PHI. After each infant receives one PRBC, the start and stop times of the PRBC are recorded on the bedside study document and then entered in the RedCap database. The excel file with the corresponding date/times and abdominal temperature for the PRBC transfusion, will be singled out to place in a large database using SPSS for the study infants.
Publications
Everhart KC, Wirth MD, Iskersky VN, Dail RB. Evaluating a blood warming device for packed red blood cell transfusions to decrease hypothermia in very preterm infants: A randomised control trial protocol. Transfus Med. 2025 Dec;35(6):582-586. doi: 10.1111/tme.13143. Epub 2025 May 15.
PubMed 40371767
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Blood Warming Device for Packed Red Blood Cell Transfusions to Decrease Hypothermia in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT05170633
- Acronym / sponsor ID
- 9040
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- The Gerber Foundation, Prisma Health-Midlands
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Standard care/Control group: The nurse will receive the PRBC transfusion from the Blood Bank. As standard care, there are no deliberate procedures for warming PRBC transfusions in this NICU. The syringe of blood may sit outside the incubator for some time and as such, will warm to the environmental ambient temperature while transfusing into the infant using a standard pump. The transfusion will be given over 4 hours, per the clinician's orders. The bedside nurse will document transfusion start and stop times, and route, on the study document at the bedside. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid. |
| Intervention | Active comparator | Device: Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)Intervention group: Once a nurse receives the PRBC from the Blood Bank, the nurse will obtain a specialized tubing and use a commercial PRBC warming device, the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) to deliver the PRBC transfusion to the infant. The unit contains highly responsive aluminum heating plates that distribute heat quickly, which responds to flow changes with even and consistent heat. The plate temperature is monitored 4 times per second and is accurate within 1°C (3M Healthcare, Oakdale, Minnesota). The Ranger blood warmer meets the American Association of Blood Bank (AABB) guidelines for warming blood. All times and information associated with the PRBC transfusion will be recorded on the bedside study document. The transfusion will be given over 4 hours, per the clinician's orders. The infant will end study participation 24 hours after the PRBC transfusion is complete to verify that all temperature data have been received and are valid. |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)70 random infant will receive the packed red blood cell transfusion with the Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) | Device | Intervention |
Primary outcome
the occurrence of hypothermia
Time frame: 12 hours of the transfusion time
the occurrence of hypothermia, defined as a mean central temperature < 36.5°C, in the intervention versus control groups
hypothermia after completion
Time frame: 1 hour post-transfusion
comparison of mean central body temperatures for the two groups, from temperatures measured after the pack red blood cell (PRBC) transfusion is complete.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 40371767Everhart KC, Wirth MD, Iskersky VN, Dail RB. Evaluating a blood warming device for packed red blood cell transfusions to decrease hypothermia in very preterm infants: A randomised control trial protocol. Transfus Med. 2025 Dec;35(6):582-586. doi: 10.1111/tme.13143. Epub 2025 May 15.
- Individual participant dataSharing planned: Yes. Once Dr. Everhart receives temperatures for each study infant, these files will be stored in a study file on the UofSC server. These data are associated with unique study numbers and contain no PHI. After each infant receives one PRBC, the start and stop times of the PRBC are recorded on the bedside study document and then entered in the RedCap database. The excel file with the corresponding date/times and abdominal temperature for the PRBC transfusion, will be singled out to place in a large database using SPSS for the study infants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranger blood warmer (3M Healthcare, Oakdale, Minnesota) in people with Preterm Birth and Blood Transfusion Complication, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of hypothermia (time frame: 12 hours of the transfusion time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.