ior EPOCIM ® in the management of anemia of the preterm infant.Phase IV.

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:

Evaluation of the safety and effectiveness of ior EPOCIM® in the management of anemia of the preterm infant.

Secondary indentifying numbers:

M9/CIMAB/AEC-2

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Ministry of Public Health(MINSAP) Center of Molecular Immunology (CIM)

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:

Trials notification

Regulatory instance:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Notification date :

12/02/2012

Reference number:

24.152.12.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:

“Diez de Octubre” Maternal Child Hospital

Postal address:

Ntra Señora de Regla No. 52. Luyanó.

City:

La Habana

Country:

Cuba

Zip Code:

Ntra Señora de Regla No. 52. Luyanó.

Telephone:

+53-6994551

Email address:

anettsijo@infomed.sld.cu [1]

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, Eusebio Hernandez Maternal -Child Hospital; Maribel Gutiérrez Becherán, MD. Specialist of first degree in Neonatology

Havana, “Enrique Cabrera” Hospital, Antonio Alfonso Dávila, MD. Specialist of second degree in Neonatology.

Havana, Guanabacoa Maternal -Child Hospital, Ana Campos González, MD. Specialist of first degree in Neonatology.

Havana, “Ramon Gonzalez Coro”Maternal -Child Hospital, Fernando Domínguez Dieppa, MD. Specialist of second degree in Neonatology.

Villa Clara, Mariana Grajales Maternal- Child Hospital, Tania Quesada Quesada, MD. Specialist of first degree in Neonatology.

Camaguey, Ana Betancourt Maternal-Child Hospital, Zeida Capote Ramírez, MD. Specialist of first degree in Neonatology.

Holguín, Vladimir Ilich Lenin Hospital, Idalmis Landrove Borjas, MD. Specialist of first degree in Neonatology.

Havana, William Soler Pediatric Hospital, Caridad Bejerano Reyes. Degree in health technology

Sancti Spíritus, Camilo Cienfuegos Hospital, Susel Abreu Rodríguez, MD. Specialist of first degree in Neonatology.

Research ethics committees:

Diez de Octubre Hospital,september 17,2012

Guanabacoa Gynecobstetrical Hospital, september 17,2012

Mariana Grajales Hospital,september 18,2012

Vladimir Ilich Lenin Hospital,september 21,2012

Eusebio Hernández Hospital, october 9,2012

Enrique Cabrera Hospital, october 22,2012

Ana Betancourt Hospital, november 21,2012

Ramón González Coro Hospital, january 23,2013

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

16/01/2013

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 newborn preterm

Intervention(s):

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 muscle) to reach the minimum weight established (2500 g),from this moment the administration will be on an outpatient basis up to 40 weeks of corrected gestational age. Vitamin: By oral route from 5 days of life, during all the time of treatment - Vitamin E (25 mg) - Vitamin C (20-60 mg) - Folic acid (1 mg) - Multivitamin complex 10 drops Ferrous fumarate: 2 - 4 mg/kg of weight per day valuing an increase up to 6 mg/kg/day, to increase the oral tolerance, that is, until the newborn receives a contribution of 100 mL/kg/day of maternal and/or artificial milk.

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):

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)

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

16 days

Maximum age:

N/A (No limit)

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.

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:

Target sample size:

121

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 y 21 N.1926 Atabey ,Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

(053)7-271 50 57 Ext.111

Email :

giselle@cim.sld.cu [2]

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

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB SA

Postal Address:

206 Street e/19 y 21 N.1926 Atabey ,Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

(053)7-271 50 57 Ext.111

Email :

giselle@cim.sld.cu [2]

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:

RPCEC00000149

Date of Registration in Primary Registry:

2013-02-26

Record Verification Date:

2015/07/17

Next update date:

2016/07/17

Link to the spanish version:

Click here [3]