Transfusion of Prematures Trial
Completed · Not applicable
Conditions studied: Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD), Anemia
In brief
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
Key facts
- Study ID
- NCT01702805
- Run by
- NICHD Neonatal Research Network
- People needed
- 1824
- Starts
- 2012-12-01
- Expected to finish
- 2025-04-29
- Last updated by the study team
- 2025-11-14
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Birth weight less than or equal to 1000 grams.
- Gestational age at least 22 weeks but less than 29 weeks
- Admitted to the NICU within 48 hours of life
You may not qualify if…
- Considered nonviable by the attending neonatologist
- Cyanotic congenital heart disease
- Parents opposed to the transfusion of blood
- Parents with hemoglobinopathy or congenital anemia
- In-utero fetal transfusion
- Twin-to-twin transfusion syndrome
- Isoimmune hemolytic disease
- Lack of parental consent
- Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.
- Prior blood transfusion on clinical grounds beyond the first 6 hours of life
- Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course
- Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.
- High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of California - Los Angeles — Los Angeles, California, United States
- Stanford University — Palo Alto, California, United States
- Emory University — Atlanta, Georgia, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- Wayne State University — Detroit, Michigan, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- University of Rochester — Rochester, New York, United States
- RTI International — Durham, North Carolina, United States
- Duke University — Durham, North Carolina, United States
- Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
- Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
- Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States
- Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
- University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
- University of Texas Health Science Center at Houston — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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