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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Robin Ohls, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01235923
First received: November 4, 2010
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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: Epoetin Alfa
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • reticulocyte count [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    retic counts measured at baseline, 2 weeks and 4 weeks


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: Epoetin Alfa
Epo 400 units/kg 3x/wk versus Epo 1,200 units/kg 1x/wk
Other Names:
  • Procrit
  • erythropoietin
Active Comparator: weekly Epo
1,200 units/kg given once a week subcutaneously for 4 weeks
 Drug: Epoetin Alfa
Epo 400 units/kg 3x/wk versus Epo 1,200 units/kg 1x/wk
Other Names:
  • Procrit
  • erythropoietin

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.

Twenty preterm infants (962±55 grams, 27.9±0.4 weeks, 17±3 days of age) were enrolled. There were no differences between groups at baseline. All infants achieved a significant increase in ARC by day 14 of the study (p=0.005 versus baseline). ARC were similar between treatment groups. Hematocrit remained stable,and similar numbers of transfusions were administered. No adverse effects of either dosing schedule were noted.

Preterm infants respond to weekly Epo by increasing ARC and maintaining hematocrit. We speculate that once weekly Epo dosing might be beneficial to preterm infants requiring increased erythropoiesis.

  Eligibility

Ages Eligible for Study:   up to 100 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robin Ohls, Professor of Pediatrics, University of New Mexico
ClinicalTrials.gov Identifier: NCT01235923     History of Changes
Other Study ID Numbers: 05-380, M01RR000997
Study First Received: November 4, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
anemia
transfusions
erythropoiesis
neonate
preterm

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013