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

Tracking Information

First Received Date ^ICMJE

November 4, 2010

Last Updated Date

June 12, 2012

Start Date ^ICMJE

April 2006

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

reticulocyte count [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

retic counts measured at baseline, 2 weeks and 4 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01235923 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Preterm Infants

Intervention ^ICMJE

Drug: Epoetin Alfa

Epo 400 units/kg 3x/wk versus Epo 1,200 units/kg 1x/wk

Other Names:

Procrit
erythropoietin

Study Arm (s)

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

Intervention: Drug: Epoetin Alfa
Active Comparator: weekly Epo
1,200 units/kg given once a week subcutaneously for 4 weeks

Intervention: Drug: Epoetin Alfa

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

Enrollment ^ICMJE

Completion Date

December 2009

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

Gender

Both

Ages

up to 100 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01235923

Other Study ID Numbers ^ICMJE

05-380, M01RR000997

Has Data Monitoring Committee

Responsible Party

Robin Ohls, University of New Mexico

Study Sponsor ^ICMJE

University of New Mexico

Collaborators ^ICMJE

National Center for Research Resources (NCRR)

Investigators ^ICMJE

Principal Investigator:

Robin K Ohls, MD

University of New Mexico

Information Provided By

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

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