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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235923
First Posted: November 8, 2010
Last Update Posted: July 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of New Mexico
  Purpose
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 Intervention Phase
Preterm Infants Drug: three times weekly Epo Drug: weekly Epo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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)


Enrollment: 20
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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
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

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 Submitted: November 4, 2010
First Posted: November 8, 2010
Results First Submitted: November 29, 2012
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


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