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Device

Blood Warming for Premature Birth

N/A
Recruiting
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to the neonatal intensive care unit receiving one PRBC transfusion within the first month of life.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours of the transfusion time
Awards & highlights

Study Summary

This trial is testing whether using a commercial blood warmer can prevent hypothermia in very preterm infants during transfusions of packed red blood cells.

Who is the study for?
This trial is for very preterm infants born at less than 32 weeks gestational age who are admitted to the neonatal intensive care unit and need a blood transfusion within their first month of life. It excludes those with major brain damage or certain neurological abnormalities, as these can affect body temperature regulation.Check my eligibility
What is being tested?
The study tests if using a commercial blood warmer during packed red blood cell transfusions can prevent hypothermia in very preterm infants. The trial randomly assigns participants to receive either warmed transfusions or standard care, aiming to compare body temperatures post-transfusion.See study design
What are the potential side effects?
While specific side effects aren't detailed for this intervention, typical concerns may include potential reactions to the warmed blood such as slight changes in vital signs; however, warming is generally considered safe and aims to reduce complications from cold infusions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My newborn was in intensive care and received a blood transfusion within the first month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours of the transfusion time
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours of the transfusion time for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
hypothermia after completion
the occurrence of hypothermia

Trial Design

2Treatment groups
Active Control
Group I: InterventionActive Control1 Intervention
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.
Group II: Standard careActive Control1 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.

Find a Location

Who is running the clinical trial?

Prisma Health-MidlandsOTHER
23 Previous Clinical Trials
2,686 Total Patients Enrolled
University of South CarolinaLead Sponsor
211 Previous Clinical Trials
120,319 Total Patients Enrolled
The Gerber FoundationOTHER
41 Previous Clinical Trials
5,856 Total Patients Enrolled

Media Library

Ranger blood warmer (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05170633 — N/A
Blood Transfusion Complications Research Study Groups: Intervention, Standard care
Blood Transfusion Complications Clinical Trial 2023: Ranger blood warmer Highlights & Side Effects. Trial Name: NCT05170633 — N/A
Ranger blood warmer (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05170633 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of at least 18 years eligible to join this experiment?

"Within the terms of this trial, any patient between 24 and 32 weeks old would qualify for enrollment."

Answered by AI

Are enrolment opportunities currently available for prospective participants of this trial?

"According to the records available on clinicaltrials.gov, this medical trial is currently recruiting patients and was initially posted in January 2022 before being modified at the end of October that same year."

Answered by AI

How many subjects are involved in this investigation?

"Affirmative. Clinical trials site clinicaltrials.gov reveals that this medical exam, which was initially published on January 1st 2022, is currently enrolling volunteers. 140 individuals are required across a single healthcare facility."

Answered by AI

Is there an opportunity to participate in this research endeavor?

"For this research, 140 subjects must be recruited that possess hypothermia and are between 24 Weeks to 32 Weeks old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Blood Warming in Preterm Infants to Decrease Hypothermia
Kayla Chavis Everhart, PhD, RN 2022. "Blood Warming in Preterm Infants to Decrease Hypothermia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05170633.
~9 spots leftby Jul 2024
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