Trial | NCT00593801  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    219
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.
Study Started
May 31
1998
Primary Completion
Jun 30
1999
Study Completion
Jun 30
1999
Last Update
Jan 15
2008
Estimate

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

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

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
No Results Posted