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SURFACEN ARDS. Pediatrics. Phase III
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30 Octubre 2014 - 10:43pm
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30 Octubre 2014 - 10:43pm
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SURFACEN ARDS. Pediatrics. Phase III
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 efficacy and safety of SURFACEN in the treatment of Acute Respiratory Distress Syndrome in pediatric patients
Secondary indentifying numbers:
9413
Issuing authority of the secondary identifying numbers:
National Center for Animal and Plant Health (CENSA)
Primary sponsor:
National Center for Animal and Plant Health (CENSA)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
National Center for Animal and Plant 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 :
16/11/2009
Reference number:
05.005.09.B
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Valentin S. Rodríguez Moya, MD. First degree specialist in pediatric. First Degree Specialist in Intensive Care and Pediatric Emergencies.
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
Research ethics committees:
Jose Luis Miranda, February 10, 2009 Eduardo Agramonte, October 13, 2008 Martires de Las Tunas, September 29, 2008 Octavio de La Concepcion, November 1, 2008 Infantil Sur, January 13, 2009 Infantil Norte, April 2, 2012
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
23/11/2010
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:
Respiratory distress syndrome in pediatric patients
Intervention(s):
Study Group (Experimental): Conventional treatment (oxygenation and mechanical ventilation) + SURFACEN at 100 mg using the endotracheal tube every 8 hours for 3 days. Control Group (Standard treatment): Conventional Treatment (oxygenation and mechanical ventilation)
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):
Condition (Alive, Dead). Measurement time: 28 days
Key secondary outcomes:
Gasometrical Evaluation (PaO2, PaCO2, pH, PaO2/FiO2, saturometry): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Ventilatory Evaluation (type of ventilation, V / minute, inspiratory tidal volume, expiratory tidal volume, respiratory rate, I/E, Pr Pico, Paw, FiO2 (default), PEEP, Static lung compliance and oxygenation index): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Clinical Evaluation (blood pressure (BP), heart rate (HR) and verify if the patient has symptoms of cyanosis (distal or generalized)): Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Radiographic Evaluation (It is measured Chest radiography. They collect the presence or absence of inflammatory infiltrates in the lung fields, and compared with respect to the first assessment, establishing the following scale: Improvement: Decrease or disappearance of pulmonary infiltrates. Stability: Maintenance of pulmonary infiltrates despite treatment. Worsening: Progression with increased pulmonary infiltrates). Measuring time: before the first administration, daily for 3 days of treatment and the fifth day after administration In the control group these time are simulated. Days of stay in the ICU (days between the date of admissions and discharge of the Intensive Care Unit). Measuring time: at the discharge of the ICU. Days of mechanical ventilation (days between the date begins to mechanically ventilated and respiratory support is withdrawn). Measuring time: When the respiratory support is withdrawn Days of endotracheal intubation (days, between the date of the patient is intubated, and the date of the extubation). Measuring time: at the extubation. Complication (description of the complications related to the ARDS and their cause). Measuring time: before enrollment, 1h and 8h after each administration. In the control group these time are simulated. Adverse Events (AE). Measuring time: daily - Description of AE (Name of the AE). - Intensity of AE (Slight, Moderate, Severe) - Severity of the AE(serious, not serious) - Time of the AE (Difference in dates for starting and ending of AE. If the AE begins and end in the same day, then the time is measured in hours and minutes). - Attitude to treatment (no change, modification of dose, Interrupted temporary, interruption ultimately), - Causal relationship (remote, possible, likely, very likely) - Treatment used for the AE (name of treatments)
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
28 days
Maximum age:
18 years
Inclusion criteria:
1. Presence of ARDS within 72 hours of diagnosis, 2. PEEP> 5 cm H2O. 3. Patients whose parents / guardians give their written consent to participate in the study. 4. Aged 28 days old and 18 years inclusive.
Exclusion criteria:
1. Onco-hematological diseases. 2. Chronic heart disease (ventricular septal defect, atrial septal defect, patent ductus arteriosus, pulmonary stenosis, coarctation of the aorta, aortic stenosis, tetralogy of Fallot, transposition of great arteries, tricuspid atresia and truncus). 3. Hypersensitivity to the surface or other component of the formulation.
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:
Randomized controlled trial
Masking:
Open
Control group:
Active
Study design:
Parallel
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:
Yinet
Last Name:
Barrese Perez
Affiliation:
National Coordinating Center for Clinical Trials (CENCEC)
Postal Address:
Calle 200 e/ 19 y 21. Atabey Playa.
City:
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:
Valentín
Last Name:
Rodriguez Moya
Affiliation:
Eduardo Agramonte Piña Pediatric Hospital
Postal Address:
Dolores Betancurt No. 2 entre Domingo Puente y Carretera Santa Cruz. La Caridad. Camagüey. Cuba
City:
Camagüey
País:
Cuba
Zip Code:
70100
Telephone:
53032-282014
Email :
mrmoya@hpc.cmw.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:
RPCEC00000163
Date of Registration in Primary Registry:
2013-06-21
Record Verification Date:
2014/10/30
Next update date:
2015/10/30
Link to the spanish version:
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