Trial Search Results
Transfusion of Prematures Trial
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.
Stanford is currently not accepting patients for this trial.
NICHD Neonatal Research Network
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
- Procedure: Liberal Cell Transfusion
- Procedure: Restricted red cell transfusion
- 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
- 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
- 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.
Ages Eligible for Study
N/A - 48 Hours
Genders Eligible for Study