Erythropoietin Treatment in Extremely Low Birth Weight Infants (EPO)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
219 participants in 3 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal