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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Effectiveness and Safety of use ior EPOCIM in the prophylaxis or treatment of anemia in the premature infant. Phase III

Secondary indentifying numbers:

IIC-RD-EC121

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

24/08/2009

Reference number:

05.018.09.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Anett

Last name:

Sijo Yero

Medical Specialty :

Neonatology

Affiliation:

10 de Octubre Maternal - Child Hospital

Postal address:

Ntra.Sra.de Regla No.52 Luyanó

City:

La Habana

País:

Cuba

Zip Code:

12000

Telephone:

+53-9664551

Email address:

anettsijo@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City, Ginecobstetric Hospital “Ramón González Coro”, Dr. Fernando Domínguez Dieppa, Neonatology.

Havana City, Ginecobstetric Hospital “Eusebio Hernández”, Dr. Leonel Méndez, Neonatology.

Havana City, Enrique Cabrera Hospital, Dr. Debora Villegas Cruz, Neonatology.

Havana City, Ginecobstetric Hospital “América Arias”, Dr. Eugenio Carro Puig, Neonatology.

Havana City, Ginecobstetric Teaching Hospital of Guanabacoa, Dr. Eulalia Mercedes Remys Pérez, Neonatology.

Research ethics committees:

Havana City, 10 de Octubre Maternal Hospital, May 15,2009.

Havana City, Ginecobstetric Hospital “Ramón González Coro”, May 6,2009.

Havana City, Ginecobstetric Hospital “Eusebio Hernández”, May 26,2009.

Havana City, Enrique Cabrera Hospital, May 31,2009.

Havana City, Ginecobstetric Hospital “América Arias”, May 14,2009.

Havana City, Ginecobstetric Hospital of Guanabacoa, December 21, 2009.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

15/10/2009

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Anemia of preterm newborn

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

8 days of birth

Maximum age:

none

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.

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

3

Target sample size:

72

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Giselle

Last Name:

Saurez Martínez

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB SA.

Postal Address:

206 street e/19 and 21 No.1926 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

537-271-50-57 Ext.111

Email :

giselle@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Giselle

Last Name:

Saurez Martínez

Affiliation:

CIMAB SA.

Postal Address:

206 street e/19 and 21 No.1926 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

537-271-50-57 Ext.111

Email :

giselle@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000088

Date of Registration in Primary Registry:

2009-10-22

Record Verification Date:

2015/07/17

Next update date:

2016/07/17

Link to the spanish version:

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

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