The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
NCT ID: NCT01203514
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
318 participants
INTERVENTIONAL
1997-08-31
2000-08-31
Brief Summary
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Detailed Description
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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 (Trial 1), we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight (Trial 2), we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.
Therapy was initiated by day of life 4 and continued through the 35th postmenstrual week. Infants were randomized to receive either Epo and iron therapy or a sham procedure. Treated infants received 400 U/kg Epo 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d. Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available. Complete blood and reticulocyte counts were measured weekly, and ferritin concentrations were measured monthly.
Transfusions were administered according to protocol. Infants did not receive a transfusion solely to replace blood lost through phlebotomy. Infants who met transfusion criteria received a transfusion of 15 mL/kg packed red blood cells (PRBC) for a hematocrit of \>25% or 20 mL/kg PRBC for a hematocrit of \<=25%. Blood losses and transfusion data were recorded.
Trial 2 was terminated after enrollment of 118 infants after the Data and Safety Monitoring Committee reviewed the final results of Trial 1 and preliminary results of Trial 2. On the basis of these data, the Committee concluded that it was statistically unlikely that Trial 2 would demonstrate a significant decrease in the percentage of infants who would receive a transfusion during the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Trial 1 Experimental
Infants 401-1,000g birthweight
Erythropoietin
Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.
Trial 1: Sham Comparator
Infants 401-1,000g birthweight
Sham Comparator
Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.
Trial 2: Experimental
Infants 1,001-1,250g birth weight
Erythropoietin
Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.
Trial 2: Sham Comparator
Infants 1,001-1,250g birth weight
Sham Comparator
Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.
Interventions
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Erythropoietin
Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.
Sham Comparator
Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Likely to survive \>72 hours
* Informed consent from a parent or guardian.
Exclusion Criteria
* 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
24 Hours
96 Days
ALL
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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University of New Mexico
Principal Investigators
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Robin K. Ohls, MD
Role: STUDY_DIRECTOR
University of New Mexico
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Ann R. Stark, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
James A. Lemons, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Sheldon B. Korones, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Richard A. Ehrenkranz, MD
Role: STUDY_DIRECTOR
Yale University
Raymond Bain, PhD
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Locations
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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
Countries
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References
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Ohls RK, Ehrenkranz RA, Wright LL, Lemons JA, Korones SB, Stoll BJ, Stark AR, Shankaran S, Donovan EF, Close NC, Das A. Effects of early erythropoietin therapy on the transfusion requirements of preterm infants below 1250 grams birth weight: a multicenter, randomized, controlled trial. Pediatrics. 2001 Oct;108(4):934-42. doi: 10.1542/peds.108.4.934.
Ohls RK, Ehrenkranz RA, Das A, Dusick AM, Yolton K, Romano E, Delaney-Black V, Papile LA, Simon NP, Steichen JJ, Lee KG; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron. Pediatrics. 2004 Nov;114(5):1287-91. doi: 10.1542/peds.2003-1129-L.
Related Links
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NICHD Neonatal Research Network
Other Identifiers
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NICHD-NRN-0017
Identifier Type: -
Identifier Source: org_study_id