Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Infants

Intervention / Treatment
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* Drug: three times weekly Epo
* Drug: weekly Epo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 100 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: three times weekly Epo<br>Epo 400 units/kg three times weekly given subcutaneously for 4 weeks | Drug: three times weekly Epo<br>* Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks<br>* Other names: Procrit;|
| Active Comparator: weekly Epo<br>1,200 units/kg given once a week subcutaneously for 4 weeks | Drug: weekly Epo<br>* Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks<br>* Other names: Procrit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Retic Count | retic count measured at study entry | baseline | 
| Reticulocyte Count | reticulocyte count at 4 weeks (end of study) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, transfusions, erythropoiesis, neonate, preterm