Overview

Erythropoietin Treatment in Extremely Low Birth Weight Infants

Status:
Completed
Trial end date:
1999-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborators:
Children's Hospital at the Bult Hannover, Germany
Children's Hospital Dortmund, Germany
Children's Hospital Koeln, Germany
Hoffmann-La Roche
Hopital Antoine Beclere
Hôpital Edouard Herriot
Olga Hospital Stuttgart, Germany
Université Catholique de Louvain
University Hospital Tuebingen
University Hospital, Aachen
University Hospital, Strasbourg, France
University of Zurich
Treatments:
Antioxidants
Epoetin Alfa
Trace Elements
Criteria
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