Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
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ClinicalTrials.gov Identifier: NCT01235923 |
Recruitment Status
:
Completed
First Posted
: November 8, 2010
Results First Posted
: July 29, 2013
Last Update Posted
: July 29, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Infants | Drug: three times weekly Epo Drug: weekly Epo | Phase 2 |
Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults with anemia due to end stage renal disease. Epo is used in preterm infants to treat the anemia of prematurity, but has not been studied using once weekly dosing. We compared reticulocyte responses of once weekly Epo dosing with thrice weekly dosing in preterm infants.
Infants ≤1,500 grams and ≥7 days of age were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts (ARC), transfusions, phlebotomy losses, and adverse events were recorded.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: three times weekly Epo
Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
|
Drug: three times weekly Epo
Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
Other Names:
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Active Comparator: weekly Epo
1,200 units/kg given once a week subcutaneously for 4 weeks
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Drug: weekly Epo
Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Other Names:
|
- Baseline Retic Count [ Time Frame: baseline ]retic count measured at study entry
- Reticulocyte Count [ Time Frame: 4 weeks ]reticulocyte count at 4 weeks (end of study)

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Ages Eligible for Study: | up to 100 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- < or = 1,500 grams
- < or = 32 weeks gestation
- > or = 7 days of age
- informed consent obtained
Exclusion Criteria:
- hemolytic disease
- hypertension
- seizures
- thromboses
- major malformation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235923
United States, New Mexico | |
UNM NICU | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Robin K Ohls, MD | University of New Mexico |
Responsible Party: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT01235923 History of Changes |
Other Study ID Numbers: |
05-380 M01RR000997 ( U.S. NIH Grant/Contract ) |
First Posted: | November 8, 2010 Key Record Dates |
Results First Posted: | July 29, 2013 |
Last Update Posted: | July 29, 2013 |
Last Verified: | June 2012 |
Keywords provided by University of New Mexico:
anemia transfusions erythropoiesis neonate preterm |
Additional relevant MeSH terms:
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Epoetin Alfa Hematinics |