The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Anemia, Neonatal
In brief
This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of \<1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.
Key facts
- Study ID
- NCT01203514
- Run by
- NICHD Neonatal Research Network
- People needed
- 318
- Starts
- 1997-08-01
- Expected to finish
- 2000-08-01
- Last updated by the study team
- 2017-09-26
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Infants with a birth weight of 4010-1250g, <32 weeks' gestation, and 24-96 hours old at the time of study entry
- Likely to survive >72 hours
- Informed consent from a parent or guardian.
You may not qualify if…
- Major congenital anomaly
- A positive direct antiglobulin test
- Evidence of coagulopathy
- Clinical seizures
- Systolic blood pressure >100 mm Hg (in the absence of pressor support)
- Absolute neutrophil count (ANC) of <=500/micro-L
Where it is running
- Yale University — New Haven, Connecticut, United States
- George Washington University — Washington D.C., District of Columbia, United States
- Emory University — Atlanta, Georgia, United States
- Indiana University — Indianapolis, Indiana, United States
- Harvard University — Cambridge, Massachusetts, United States
- Wayne State University — Detroit, Michigan, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
- University of Tennessee — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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