Effectiveness and safety of ior EPOCIM in anemia in premature infant.
Phase 3
- Conditions
- Anemia of preterm newborn
- Registration Number
- RPCEC00000088
- Lead Sponsor
- Center of Molecular Immunology(CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
1.Preterm patients with weight = 1500 g and gestational age <34 weeks(determined by the method of date of last menstrual period). 2.Patients whose parent or responsible family has given its consent for participation in the study in writing.
3.Patients with more than 7 days old.
4.Patients with an intake of at least 50 ml/kg/ day of milk and/or artificial.
Exclusion Criteria
1.Patients with hemolytic or hemorrhagic disease.
2.Patients diagnosed with major congenital malformation requiring transfer to another department of Neonatology.
3.Patients with known hypersensitivity to products derived from cells above or hypersensitivity to human albumin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transfusional requirement from red globules (Yes, No). Measurement time: at the end of treatment and 30 days after end of treatment.
- Secondary Outcome Measures
Name Time Method