Anemia of preterm newborn
Conditions
Interventions
Schema: ior® EPOCIM+ Vitamin therapy + Ferric supplement ior® EPOCIM 900 IU/kg/per week (subcutaneosly), 3 times for week, 300 IU/kg in each administration, in the right deltoid region. It will admini
allowed scale up 6 mg/kg/day, according oral tolerability, until premature infant take in 100 ml/kg/day of maternal milk and/or artifitial milk. All treatments will finish when the patient reaches cor
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transfusional requirement from red globules (Yes, No). Measurement time: at the end of treatment and 30 days after end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of red globules transfusions required (total of transfusions of blood required by the patient). Measurement time: at the end of treatment and 30 days after end of treatment. Hematological status: Hemoglobin (g/l) and Hematocrit (%). Time of measurement: baseline, 7, 15, 30 and 45 days of treatment, at the end of treatment and 30 days after end of treatment. Adverse Events (AE). Measurement time: 7, 15, 30 and 45 days of treatment, at the end of treatment and 30 days after end of treatment. - AE occurrence in the subject (Yes/No) - AE description (name of the AE) - AE duration (different between of start date and the end date of the AE) - AE Intensity (Mild, Moderate, Severe) - AE severity (Grave/Serious, Not Grave/ Not Serious) - Attitude from study treatment (Without change, Modification of doses, Temporal withdrawal, Definitive withdrawal from treatment) - AE outcome (Recovered, Improved, Sequelae, Persists, Death) - Casualty related (1.Very probably, 2.Probably 3.Possible, 4.Improbably, 5.Not related 6.Not evaluate) | — |
Countries
Cuba
Contacts
Public ContactGiselle Saurez Martínez
CIMAB SA.
Outcome results
None listed