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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

NCT01235923 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-21

Study results available
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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.

Conditions

  • Preterm Infants

Interventions

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

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Robin K Ohls, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
100 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-03-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235923 on ClinicalTrials.gov