Erythropoietin Treatment in Extremely Low Birth Weight Infants

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

Conditions

• Infant, Low Birth Weight
• Anemia

Interventions

DRUG

epoetin 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

DRUG

epoetin beta

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

Sponsors & Collaborators

• Hoffmann-La Roche

  collaborator INDUSTRY

• University Hospital Tuebingen

  collaborator OTHER

• Children's Hospital at the Bult Hannover, Germany

  collaborator UNKNOWN

• University Hospital, Aachen

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• Children's Hospital Koeln, Germany

  collaborator UNKNOWN

• Université Catholique de Louvain

  collaborator OTHER

• Children's Hospital Dortmund, Germany

  collaborator UNKNOWN

• Hopital Antoine Beclere

  collaborator OTHER

• Hôpital Edouard Herriot

  collaborator OTHER

• Olga Hospital Stuttgart, Germany

  collaborator UNKNOWN

• University Hospital, Strasbourg, France

  collaborator OTHER

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Michael Obladen, Prof.Dr. · Charité Berlin, University Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

3 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-05-31

Primary Completion

1999-06-30

Completion

1999-06-30

Countries

• Germany

Study Locations