ior EPOCIM ® in the management of anemia of the preterm infant.Phase IV.
Phase 4
- Conditions
- Anemia of newborn preterm
- Registration Number
- RPCEC00000149
- Lead Sponsor
- Center of Molecular Immunology(CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 121
Inclusion Criteria
1.Preterm patients with weight = 1500 g and gestational age < 34 weeks (determined by the method of date of last menstruation. 2.Patients whose parent or responsible family member has granted your consent to participation in the study in writing.
3.Patients with more than 15 days old.
4.Patients with an intake of at least 50 mL/kg/day of maternal and/or artificial milk.
Exclusion Criteria
1.Patients with diagnosis of hemorrhagic or hemolytic disease.
2.Patients with a diagnosis of major congenital malformation requiring transfer to another service of Neonatology.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events (AE) related to the administration of ior ® EPOCIM with causal relationship (Probable or very Probable). Measurement time: 24 months - Occurrence of any AE (Yes, No) - Description of the AE (name of the event) - Duration of the AE ( it will be evaluated by the difference in dates between the start and the completion of the AE) - Intensity of the AE (1. Mild, 2.Moderate, 3.Severe) - Severity of the AE (Severe/serious or Not Severe /Non Serious) - Attitude towards treatment in study (no change, modification of dose, temporary or definitive interruption of treatment in study) - Result of the AE (recovered, improved, squeals, persists or death) - Causality relationship (1.Very likely, 2.Probable, 3.Possible, 4.Unlikely, 5.Unrelated, 6.Not valuable)
- Secondary Outcome Measures
Name Time Method