Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

University of New Mexico (UNM)

Status and phase: Completed; Phase 2

Conditions: Preterm Infants

Treatments: Drug: weekly Epo; Drug: three times weekly Epo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01235923

M01RR000997 (U.S. NIH Grant/Contract)

05-380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 7 to 100 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

three times weekly Epo

Active Comparator group

Description:

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

Treatment:

Drug: three times weekly Epo

weekly Epo

Active Comparator group

Description:

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

Treatment:

Drug: weekly Epo