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.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Liberal Cell Transfusion
  • Procedure: Restricted red cell transfusion

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Birth weight less than 1000 grams.

   - Gestational age at least 22 weeks but less than 29 completed weeks

   - Admitted to the NICU within 48 hours of life

Exclusion Criteria:

   - 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

   - 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa P. Van Meurs, MD
650-723-5711
Not Recruiting