Effectiveness and safety of ior EPOCIM in anemia in premature infant.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000088
• Date of registration: 22/10/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Effectiveness and safety of ior EPOCIM in anemia in premature infant.
• Scientific title: Effectiveness and Safety of use ior EPOCIM in the prophylaxis or treatment of anemia in the premature infant.Phase III
• Date of first enrolment: 15/10/2009
• Target sample size: 72
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000088-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Giselle Saurez
• Affiliation: CIMAB SA.

• Name: Giselle Saurez
• Affiliation: CIMAB SA.

Key inclusion & exclusion 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: 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.

Age minimum: 8 days of birth
Age maximum: none
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia in the premature infant.

Intervention(s)

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 administer in patient hospitalized. If the premature infant have the minimal weight established (2500 g), the administration will be in ambulatory way. Vitamin therapy (oral route): VitaminE (25 mg), Vitamin C (50 mg), Folic acid (1mg) and Multivitamin complex 6 dropes. This treatment will begin since 5 days of life, like appears in the protocol of the newborn that are low weight. Ferric supplement (Ferrous fumarate) by oral route. Doses 4 mg/kg/day; 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 corrected gestational age of 40 weeks.

Primary Outcome(s)

Transfusional requirement from red globules (Yes, No). Measurement time: at the end of treatment and 30 days after end of treatment.

Secondary Outcome(s)

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)

Secondary ID(s)

IIC-RD-EC121

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable