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| ID | Type | Description | Link |
|---|---|---|---|
| Hoffmann- La Roche,MF 4481 |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| University Hospital Tuebingen | OTHER |
| Children's Hospital at the Bult Hannover, Germany | UNKNOWN |
| University Hospital, Aachen |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2: late rhEPO | Active Comparator | late EPO treatment from the fourth week for 6 weeks |
|
| 3: no EPO | No Intervention | control group, no EPO treatment | |
| 1: early rhEPO | Active Comparator | early rhEPO treatment from the first week until 9 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin beta | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| transfusion need | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| concentrations of trace elements and antioxidant enzymes in the blood | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Obladen, Prof.Dr. | Charité Berlin, University Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Neonatolgy Charité University Medicine Berlin | Berlin | State of Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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| OTHER |
| University of Zurich | OTHER |
| Children's Hospital Koeln, Germany | UNKNOWN |
| Université Catholique de Louvain | OTHER |
| Children's Hospital Dortmund, Germany | UNKNOWN |
| Hopital Antoine Beclere | OTHER |
| Hôpital Edouard Herriot | OTHER |
| Olga Hospital Stuttgart, Germany | UNKNOWN |
| University Hospital, Strasbourg, France | OTHER |
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| epoetin beta | Drug | 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 |
|