Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

NCT ID: NCT01235923

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-12-31

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.

Conditions

Preterm Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

three times weekly Epo

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

Group Type: ACTIVE_COMPARATOR

three times weekly Epo

Intervention Type: DRUG

Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks

weekly Epo

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

Group Type: ACTIVE_COMPARATOR

weekly Epo

Intervention Type: DRUG

Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks

Interventions

three times weekly Epo

Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks

Intervention Type: DRUG

weekly Epo

Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks

Intervention Type: DRUG

Other Intervention Names

Epoetin alfa; Procrit; Epoetin alfa; Procrit

Eligibility 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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 100 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin K Ohls, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

UNM NICU

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

M01RR000997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-380

Identifier Type: -

Identifier Source: org_study_id