Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

Phase 2

Completed

• Conditions: Preterm Infants
• Interventions: Drug: three times weekly Epo; Drug: weekly Epo

• Registration Number: NCT01235923
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-03
• Study Completion: 2009-12
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-08
• Status Verified: 2012-06
• Results First Submitted: 2012-11-29
• Results First Submitted QC: 2013-06-19
• Results First Posted: 2013-07-29
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
three times weekly Epo	three times weekly Epo	Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
weekly Epo	weekly Epo	1,200 units/kg given once a week subcutaneously for 4 weeks

Primary Outcome Measures

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

Trial Locations

Locations (1)

UNM NICU; 🇺🇸 Albuquerque, New Mexico, United States