Erythropoietin Treatment in Extremely Low Birth Weight Infants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00593801

Acronym

EPO

Enrollment

219

Registered

2008-01-15

Start date

1998-05-31

Completion date

1999-06-30

Last updated

2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Infant, Low Birth Weight

Keywords

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

Brief summary

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

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.

Interventions

DRUGepoetin beta

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 3 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
transfusion need	9 weeks

Secondary

Measure	Time frame
concentrations of trace elements and antioxidant enzymes in the blood	9 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026