drugset / Trial / NCT00593801
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Completed
219 enrolled
Charite University, Berlin, Germany
Children's Hospital Dortmund, Germany · collabChildren's Hospital Koeln, Germany · collabChildren's Hospital at the Bult Hannover, Germany · collabHoffmann-La Roche · collabHopital Antoine Beclere · collabHôpital Edouard Herriot · collabOlga Hospital Stuttgart, Germany · collabUniversity Hospital Tuebingen · collabUniversity Hospital, Aachen · collabUniversity Hospital, Strasbourg, France · collabUniversity of Zurich · collabUniversité Catholique de Louvain · collab
RandomizedParallel-groupTriple-blindTreatment
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
Timeline
- Start
- 1998-05
- Primary completion
- 1999-06
- Completion
- 1999-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin alfa | Protein / enzyme biologic | 250 iu/kg | Subcutaneous |