Blood Warming in Preterm Infants to Decrease Hypothermia

NCT05170633 | Recruiting FDA Device

• 1 other identifier: 9040
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Blood Transfusion Complication; Hypothermia

Outcome Measures

Primary Outcomes (2)

• the occurrence of hypothermia

  the occurrence of hypothermia, defined as a mean central temperature \< 36.5°C, in the intervention versus control groups

  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.

  1 hour post-transfusion

Study Arms (2)

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.

Device: Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)

Interventions

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)

Intervention

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants having neurological anatomical abnormalities or major brain hemorrhage (Grade III or IV), because neurological damage can interfere with thermal control.

Sponsors & Collaborators

• University of South Carolina: lead
• The Gerber Foundation: collaborator
• Prisma Health-Midlands: collaborator

Study Sites (1)

Kayla Everhart

Columbia, South Carolina, 29208, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40371767 DERIVED

MeSH Terms

Conditions

Premature Birth; Transfusion Reaction; Hypothermia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 28, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Life of the study

Locations

US (1)