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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
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of New Mexico

Study Description
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Brief Summary:
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing usually occurs three times a week, but extended dosing schedules have been successful in adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard three times weekly dosing.

Condition or disease Intervention/treatment Phase
Preterm Infants Drug: three times weekly Epo Drug: weekly Epo Phase 2

Detailed Description:

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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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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:
  • Epoetin alfa
  • Procrit
Active Comparator: weekly Epo
1,200 units/kg given once a week subcutaneously for 4 weeks
 Drug: weekly Epo
Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Other Names:
  • Epoetin alfa
  • Procrit


Outcome Measures
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Primary Outcome Measures :
  1. Baseline Retic Count [ Time Frame: baseline ]
    retic count measured at study entry

  2. Reticulocyte Count [ Time Frame: 4 weeks ]
    reticulocyte count at 4 weeks (end of study)


Eligibility Criteria
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Ages Eligible for Study:   up to 100 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, New Mexico
UNM NICU
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Robin K Ohls, MD University of New Mexico
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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