Red Cell Transfusions for Premature Infants
(TOP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best method for administering blood transfusions to extremely low birth weight (ELBW) premature infants. Researchers aim to determine if maintaining higher hemoglobin levels (the protein in red blood cells that carries oxygen) enhances survival and brain development compared to usual care. The trial includes two groups: one receives liberal red cell transfusions at higher hemoglobin levels, while the other follows standard practice with restricted red cell transfusions at lower levels. Newborns weighing 1000 grams or less and admitted to the NICU within their first two days are suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to potentially life-saving advancements in neonatal care.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both flexible and strict approaches to red blood cell transfusions are generally safe for anemic preterm infants. A review of 12 studies found these methods effective and safe. Other studies found no major differences in survival rates or brain development when using higher or lower hemoglobin levels to guide transfusions. This indicates both methods are well-tolerated. However, debate continues about the optimal level for preterm babies. Overall, evidence indicates that the treatments under study are safe for humans.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores how different thresholds for red cell transfusions could improve care for premature infants. Unlike the standard practice of using a lower hemoglobin threshold for transfusions, the trial also examines a higher threshold to see if it offers better outcomes for these vulnerable patients. The hope is that by comparing these two approaches, researchers can better understand which method leads to healthier development and fewer complications in premature infants. This could potentially redefine best practices for blood transfusions in neonatal care.
What evidence suggests that this trial's treatments could be effective for premature infants?
This trial will compare two transfusion strategies for premature infants: High Threshold Transfusion and Low Threshold Transfusion. Research has shown that giving more blood transfusions to premature babies does not improve their chances of surviving without brain development issues by age 2. Studies have found that both more and fewer transfusions are generally safe and effective for anemic preterm babies. However, current guidelines often recommend fewer transfusions, as this might benefit babies born early. Blood transfusions are linked to long-term brain development, affecting how the brain grows over time. Therefore, selecting the right transfusion plan is crucial for the health and development of premature infants.12367
Who Is on the Research Team?
Bradley Yoder, MD
Principal Investigator
University of Utah
Carl T D'Angio, MD
Principal Investigator
University of Rochester
Michele C Walsh, MD MS
Principal Investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Waldemar A Carlo, MD
Principal Investigator
University of Alabama at Birmingham
Myra Wyckoff, MD
Principal Investigator
University of Texas, Southwestern Medical Center at Dallas
Abbot R Laptook, MD
Principal Investigator
Brown University, Women & Infants Hospital of Rhode Island
Krisa P Van Meurs, MD
Principal Investigator
Stanford University
Pablo Sanchez, MD
Principal Investigator
Research Institute at Nationwide Children's Hospital
C. Michael Cotten, MD
Principal Investigator
Duke University
Kristi L Watterberg, MD
Principal Investigator
University of New Mexico
Ravi Patel, MD
Principal Investigator
Emory University
Uday Devaskar, MD
Principal Investigator
University of California, Los Angeles
Haresh M Kirpalani, MD
Principal Investigator
University of Pennsylvania
William Truog, MD
Principal Investigator
Children's Mercy Hospital Kansas City
Abhik Das, PhD
Principal Investigator
RTI International
Beena Sood, MD
Principal Investigator
Wayne State University
Kathleen A Kennedy, MD MPH
Principal Investigator
The University of Texas Health Science Center, Houston
Brenda Poindexter, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Greg Sokol, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
The TOP trial is for extremely low birth weight infants with a gestational age of 22-28 weeks, admitted to the NICU within 48 hours of life, and weighing less than or equal to 1000 grams. Infants who've had prior transfusions (beyond first 6 hours), received erythropoietin, have congenital conditions affecting survival/neurodevelopment, severe acute conditions, or whose parents cannot attend follow-up are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants are randomized to receive red blood cell transfusions according to either a high or low hemoglobin threshold strategy
Follow-up
Participants are monitored for survival and neurodevelopmental impairment at 22-26 months corrected age
Extended Follow-up
Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess neurological and functional outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Liberal Cell Transfusion
- Restricted red cell transfusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
NICHD Neonatal Research Network
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator