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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

Primary Purpose

Preterm Infants

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
three times weekly Epo
weekly Epo
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants focused on measuring anemia, transfusions, erythropoiesis, neonate, preterm

Eligibility Criteria

7 Days - 100 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNM NICU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

three times weekly Epo

weekly Epo

Arm Description

Epo 400 units/kg three times weekly given subcutaneously for 4 weeks

1,200 units/kg given once a week subcutaneously for 4 weeks

Outcomes

Primary Outcome Measures

Baseline Retic Count
retic count measured at study entry
Reticulocyte Count
reticulocyte count at 4 weeks (end of study)

Secondary Outcome Measures

Full Information

First Posted
November 4, 2010
Last Updated
May 24, 2022
Sponsor
University of New Mexico
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01235923
Brief Title
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Official Title
A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
anemia, transfusions, erythropoiesis, neonate, preterm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
three times weekly Epo
Arm Type
Active Comparator
Arm Description
Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
Arm Title
weekly Epo
Arm Type
Active Comparator
Arm Description
1,200 units/kg given once a week subcutaneously for 4 weeks
Intervention Type
Drug
Intervention Name(s)
three times weekly Epo
Other Intervention Name(s)
Epoetin alfa, Procrit
Intervention Description
Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
Intervention Type
Drug
Intervention Name(s)
weekly Epo
Other Intervention Name(s)
Epoetin alfa, Procrit
Intervention Description
Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Primary Outcome Measure Information:
Title
Baseline Retic Count
Description
retic count measured at study entry
Time Frame
baseline
Title
Reticulocyte Count
Description
reticulocyte count at 4 weeks (end of study)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
100 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin K Ohls, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNM NICU
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

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