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):

University of New Mexico

ClinicalTrials.gov Identifier:

NCT01235923

First received: November 4, 2010

Last updated: June 19, 2013

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: three times weekly Epo Drug: weekly Epo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants

Resource links provided by NLM:

Drug Information available for: Epoetin Alfa

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

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)


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: 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
Active Comparator: weekly Epo 1,200 units/kg given once a week subcutaneously for 4 weeks	Drug: weekly Epo Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks Other Names: Epoetin alfa Procrit

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.

Eligibility


Ages Eligible for Study:	up to 100 Days (Child)
Sexes Eligible for Study:	All
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

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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


Responsible Party:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT01235923 History of Changes
Other Study ID Numbers:	05-380 M01RR000997 ( US NIH Grant/Contract Award Number )
Study First Received:	November 4, 2010
Results First Received:	November 29, 2012
Last Updated:	June 19, 2013

Keywords provided by University of New Mexico:


anemia transfusions erythropoiesis neonate preterm

Additional relevant MeSH terms:


Premature Birth Obstetric Labor, Premature Obstetric Labor Complications	Pregnancy Complications Epoetin Alfa Hematinics

ClinicalTrials.gov processed this record on June 23, 2017

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