Erythropoietin Treatment in Extremely Low Birth Weight Infants

Study Overview
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Brief Summary
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Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment. The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Study population: 219 patient randomized into 3 groups

Detailed Description
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Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%. The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.

Official Title
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Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity

Conditions
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Infant, Low Birth Weight, Anemia

Intervention / Treatment
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* Drug: epoetin beta
* Drug: epoetin beta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extremely low birth weight infants Exclusion Criteria: Cyanotic heart disease Major congenital malformation requiring surgery Gestational age > 30 weeks Administration of an investigational drug during pregnancy Lack of parental consent

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2: late rhEPO<br>late EPO treatment from the fourth week for 6 weeks | Drug: epoetin beta<br>* 250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day<br>|
| No Intervention: 3: no EPO<br>control group, no EPO treatment | |
| Active Comparator: 1: early rhEPO<br>early rhEPO treatment from the first week until 9 weeks | Drug: epoetin beta<br>* 250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion need |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentrations of trace elements and antioxidant enzymes in the blood |  | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extremely low birth weight infants, transfusion need, erythropoietin, trace elements, antioxidant enzymes, reduction of the transfusion need by EPO treatment, trace elements and antioxidant enzymes in blood