Early use of surfacen in the respiratory distress syndrome of the newborn. 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 effectiveness and safety of SURFACEN early use for the Newborn Respiratory Distress Syndrome. Phase IV

Secondary indentifying numbers:

SU07/08

Issuing authority of the secondary identifying numbers:

CENSA

Source(s) of monetary or material support:

National Center for Animal Plant and Health (CENSA) Ministry of Public Health (MINSAP)

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 :

31/05/2010

Reference number:

24-046-10-B

Principal investigator

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

First name:

Andrés Morilla Guzmán, MD. Specialist of 1st degree of neonatology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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:

Pinar del Río,Abel Santamaría, Dra. Ivón Sánchez Monterrey La Habana, Iván Portuondo, Dra. Yanet García Fernández Ciudad de la Habana, Eusebio Hernández, Dra. Tatiana Dávalos Sarría Ciudad de la Habana, América Áreas, Dra. Odalys Céspedes Barriento Ciudad de la Habana, Hospital Materno de 10 de Octubre, Dra. Anadelis Torres López Matanzas, Hospital Materno Julio Alfonso Medina, Dra. Nancy Toledo Santana Cienfuegos, Gustavo Aldereguía, Dra. Esther Cano Andino Villa Clara, Mariana Grajales, Dra. Lilian Llerena Dominguez Sanctí Spíritus, Camilo Cienfuegos, Dra. Midalis Martínez Barrios Ciego de Ávila, Antonio Luaces, Dra. Ana Iskra Meizoso Valdes Camagüey, Ana Betancourt, Dr. Heriberto de Jesus Murray Las Tunas, Ernesto Guevara, Dra. María A. Sotolongo Castillo Holguín, Vladimir I. Lenin, Dra. Idalmis Landrove Borjac Granma-Bayamo, Carlos M. de Céspedes, Dra. María C. Estévez Llovet Granma-Manzanillo, Fé del Valle, Dr. Alfredo Jimenez Nogera Santiago de Cuba, Hospital Materno Norte Tamara Bunke,Dra. Idania Pena Lora Guantánamo, Agostinho Neto, Dra. Yohandra Morales Urgón

Research ethics committees:

Angel Arturo Aballi (CH), March 9, 2010 Abel Santamaria (PR), 6 January 2010 Ivan Portuondo (HB), March 23, 2010 Eusebio Hernández (CH), February 22, 2010 America Areas (CH), March 1, 2010 Hospital Materno 10 de Octubre (CH), December 22, 2009 Julio Alfonso Medina Hospital Materno, January 22, 2010 Gustavo Aldereguía (CF), March 26, 2010 Mariana Grajales (VC), January 11, 2010 Camilo Cienfuegos (SS), January 12, 2010 Antonio Luaces (CA), September 13, 2010 Ana Betancourt, January 12, 2010 Ernesto Guevara (LT), June 10, 2010 Vladimir I. Lenin (HO), September 24, 2010 Carlos M. Cespedes (GR-BY), January 26, 2010 Fe del Valle (GR-MZ), September 9, 2010 Tamara Bunke Maternity Hospital North (SC), December 25, 2009 Agostinho Neto (GT), 14 January 2010

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

01/06/2010

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:

Newborn Respiratory Distress Syndrome

Intervention(s):

Surfacen: A dose of 100 mg/kg by endotracheal instillation. The administration will ocurr in the first two hours of life, after the patient is stable hemodynamically and metabolically. If required, may be administered other 3 doses within 72 hours.

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):

Total time of ventilation: time reported in hours/days, between begin and the end of the ventilation. Measuring time: 28 days.

Key secondary outcomes:

Value of PaO2/FiO2. Measuring time: 1 hour and 4 hours after the first dose of SURFACEN Need for prolonged ventilation (Yes / No). Measuring time: 7 days. Complication Type of Ventilation: complication (s) that occurs in the patient (bronchopulmonary dysplasia, air lock, retinopathy of prematurity, respiratory failure, etc) will be collected (n) (s). Measuring time: 28 days.

Selection criterias

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

Gender:

Male/Female

Minimum age:

no

Maximum age:

2 hours old

Inclusion criteria:

1. Newborn of less than 2 hours 2. Gestational age between 26-36 weeks, both inclusive 3. Patients who meet the criteria of early use of SURFACEN 4. Patient's mother (and/or Patient's father) who expressed voluntarily the participation in the study with the signature of the Informed Consent

Exclusion criteria:

1. Major congenital malformations 2. Severe infections 3. Bronchoaspiration of the meconial amniotic liquid 4. Intrapartum asphyxia 5. Pneumothorax or pneumomediastinum before the beginning of the treatment with SURFACEN. 6. Pulmonary hemorrhage before the beginning of the treatment with SURFACEN

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:

4

Target sample size:

No applicable. Inclusion for 2 years

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:

Yinet

Last Name:

Barrese Pérez

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

Calle 200 e/ 19 y 21. Atabey Playa. Zip Code 11600.

City:

Ciudad de la Habana

País:

Cuba

Zip Code:

11600

Telephone:

537-271-7345 537-271-7397

Email :

yinet@cencec.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:

Dr. Andrés

Last Name:

Morilla Guzmán

Affiliation:

Hospital Ángel Arturo Aballí

Postal Address:

Calzada de Bejucal km 7 ½ s/n Arrollo Naranjo.

City:

Ciudad de la Habana

País:

Cuba

Zip Code:

-

Telephone:

537-643-1878

Email :

andres.morilla@infomed.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:

RPCEC00000099

Date of Registration in Primary Registry:

2011-04-18

Record Verification Date:

2012-06-11 20:00

Link to the spanish version:

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Early use of surfacen in the respiratory distress syndrome of the newborn. Phase IV

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