NCT01235923

Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 7 Days – 100 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infants

Interventions

Type	Name	Description
DRUG	three times weekly Epo	Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
DRUG	weekly Epo	Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-03-01
• Completion: 2009-12-01
• First posted: 2010-11-08
• Last updated: 2022-06-21
• Results posted: 2013-07-29

Locations

1 site across 1 country: United States