Anemia of newborn preterm
Conditions
Interventions
Treatment: ior® EPOCIM+ Vitamin+ Ferrous fumarate. ior® EPOCIM: Dose:900 IU/kg body weight/week,3 times per week,300 IU/kg in each administration by subcutaneous route (in the region of the deltoid mu
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Age
16 Days to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Transfusion requirements (Yes, No). Measurement time: 24 months. Number of transfusions required (total of transfusions). Measurement time: 24 months. Hemoglobin (in g/l). Measurement time: initial evaluation (at the time of inclusion), 30 days, 40 a week corrected gestational age, a month after completed the treatment, and 3 Months, 6 months, 9 months, 12 months and the 18th months of corrected gestational age. Hematocrit (in %). Measurement time: initial evaluation (at the time of inclusion), 30 days, 40 a week corrected gestational age, a month after completed the treatment, and 3 Months, 6 months, 9 months, 12 months and the 18th months of corrected gestational age. Volume of blood transfused (in mL). Measurement time:24 months. Neurodevelopmental assessment (Test of Amiel-Tison). Measurement time: after 3 months of corrected gestational age, with a quarterly frequency up to 12 months of corrected gestational age and then to 18 months of corrected gestational age. Evaluation of mental and motor development (Bayley scale). Measurement time: 6 months, 12 months and 18 months of life. Presence of retinopathy (Yes, No. It will be evaluated by Oftalmological exam). Measurement time: between 3 and 6 months of corrected gestational age. Presence of auditory deficit (Yes, No. It will be evaluated by Brain stem auditory evoked potentials in the institution that possible). Measurement time: 3 months of corrected gestational age. Electroencephalogram and visual evoked potential. Measurement time: 3 months of corrected gestational age. | — |
Countries
Cuba
Contacts
Public ContactGiselle Saurez Martínez
CIMAB SA
Outcome results
None listed