Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01235923
First received: November 4, 2010
Last updated: June 19, 2013
Last verified: June 2012

November 4, 2010
June 19, 2013
April 2006
March 2009   (final data collection date for primary outcome measure)
  • Baseline Retic Count [ Time Frame: baseline ] [ Designated as safety issue: No ]
    retic count measured at study entry
  • Reticulocyte Count [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    reticulocyte count at 4 weeks (end of study)
reticulocyte count [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
retic counts measured at baseline, 2 weeks and 4 weeks
Complete list of historical versions of study NCT01235923 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Preterm Infants
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
up to 100 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01235923
05-380, M01RR000997
No
University of New Mexico
University of New Mexico
National Center for Research Resources (NCRR)
Principal Investigator: Robin K Ohls, MD University of New Mexico
University of New Mexico
June 2012

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