The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
EPO
17 other identifiers
interventional
318
1 country
9
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 1997
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedSeptember 26, 2017
September 1, 2017
1 year
September 15, 2010
September 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Erythrocyte transfusions in infants 401-1,000g birthweight
Hospital discharge or 35 weeks postmenstrual age
Blood transfusions
Hospital discharge or 35 weeks postmenstrual age
Study Arms (4)
Trial 1 Experimental
EXPERIMENTALInfants 401-1,000g birthweight
Trial 1: Sham Comparator
SHAM COMPARATORInfants 401-1,000g birthweight
Trial 2: Experimental
EXPERIMENTALInfants 1,001-1,250g birth weight
Trial 2: Sham Comparator
SHAM COMPARATORInfants 1,001-1,250g birth weight
Interventions
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.
Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Yale University
New Haven, Connecticut, 06504, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Harvard University
Cambridge, Massachusetts, 02138, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Related Publications (2)
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.
PMID: 11581447RESULTOhls 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.
PMID: 15520109RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robin K. Ohls, MD
University of New Mexico
- PRINCIPAL INVESTIGATOR
Edward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
- PRINCIPAL INVESTIGATOR
Barbara J. Stoll, MD
Emory University
- PRINCIPAL INVESTIGATOR
Ann R. Stark, MD
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
James A. Lemons, MD
Indiana University
- PRINCIPAL INVESTIGATOR
Sheldon B. Korones, MD
University of Tennessee
- PRINCIPAL INVESTIGATOR
Seetha Shankaran, MD
Wayne State University
- STUDY DIRECTOR
Richard A. Ehrenkranz, MD
Yale University
- PRINCIPAL INVESTIGATOR
Raymond Bain, PhD
George Washington University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
August 1, 1997
Primary Completion
August 1, 1998
Study Completion
August 1, 2000
Last Updated
September 26, 2017
Record last verified: 2017-09