Status:
COMPLETED
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
24-96 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Critically ill preterm infants experience in the first 1-2 weeks after birth daily blood losses that may equal 5-10% of their total blood volume. Such losses and associated anemia typically result in ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2000
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT01203514
Start Date
August 1 1997
End Date
August 1 2000
Last Update
September 26 2017
Active Locations (9)
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1
Yale University
New Haven, Connecticut, United States, 06504
2
George Washington University
Washington D.C., District of Columbia, United States, 20052
3
Emory University
Atlanta, Georgia, United States, 30303
4
Indiana University
Indianapolis, Indiana, United States, 46202