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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

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.
 
ClinicalTrials.gov Identifier: NCT01235923
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : July 29, 2013
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of New Mexico

Tracking Information
First Submitted Date  ICMJE November 4, 2010
First Posted Date  ICMJE November 8, 2010
Results First Submitted Date  ICMJE November 29, 2012
Results First Posted Date  ICMJE July 29, 2013
Last Update Posted Date June 21, 2022
Study Start Date  ICMJE April 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
reticulocyte count [ Time Frame: 4 weeks ]
retic counts measured at baseline, 2 weeks and 4 weeks
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Official Title  ICMJE A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Preterm Infants
Intervention  ICMJE
  • 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
  • Drug: weekly Epo
    Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
    Other Names:
    • Epoetin alfa
    • Procrit
Study Arms  ICMJE
  • Active Comparator: three times weekly Epo
    Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
    Intervention: Drug: three times weekly Epo
  • Active Comparator: weekly Epo
    1,200 units/kg given once a week subcutaneously for 4 weeks
    Intervention: Drug: weekly Epo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2010)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Days to 100 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01235923
Other Study ID Numbers  ICMJE 05-380
M01RR000997 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of New Mexico
Original Responsible Party Robin Ohls, MD, UNM
Current Study Sponsor  ICMJE University of New Mexico
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Robin K Ohls, MD University of New Mexico
PRS Account University of New Mexico
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP