Safety and effectiveness of SURFACEN® combined with the conventional therapy, in the treatment of ARDS in pediatrics. National extension

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:

Safety and effectiveness of SURFACEN® combined with the conventional therapy, in the treatment of the Acute Respiratory Distress Syndrome in pediatrics. National extension

Secondary indentifying numbers:

FONCI9449

Issuing authority of the secondary identifying numbers:

National Center for Animal and Plant Health (CENSA)

Source(s) of monetary or material support:

National Center for Animal and Plant Health (CENSA)

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 :

21/07/2017

Reference number:

37.004.17Bf4

Principal investigator

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

First name:

Valentin

Midle name:

Santiago

Last name:

Rodriguez Moya

Medical Specialty :

1st Degree Specialist in Pediatrics, 2nd Degree Specialist in Pediatric Intensive Medicine, Assistant Professor

Affiliation:

Teaching Community Polyclinic Ignacio Agramonte Loynaz

Postal address:

Cornelio Porro, Esquina a 3ra, Camaguey

City:

Camaguey

País:

Cuba

Zip Code:

70100

Telephone:

+53-32336294

+53-32336275

Email address:

mrmoya@finlay.cmw.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:

Pinar del Rio, “Pepe Portillo” Hospital, Eddy Gonzalez Ungo, MD. 1st Degree Specialist in Intensive Medicine and Emergency

La Habana, “Angel Arturo Aballi” Hospital, Laura M. Sanchez Perez, MD. 1st Degree Specialist in Integral General Medicine (IGM), 1st Degree Specialist in Pediatrics, Pediatric Intensive Care Specialist

La Habana, “Juan Manuel Marquez” Hospital, Leonor Verdecia Sanchez, MD. Specialist in Pediatrics and Intensive Medicine

Matanzas, “Eliseo Noel Camacho” Hospital, Wapnia Mireya Gonzalez Imper, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Cienfuegos, “Paquito Gonzalez” Hospital, Erdwis Perez Pintado, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Villa Clara, “Jose Luis Miranda” Hospital, Yamilet Segredo Molina, MD. 2nd Degree Specialist in Intensive Medicine and Emergency

Sancti Spiritus, “Jose Marti” Hospital, Frank Felipe Martin, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Las Tunas, “Martires de Las Tunas” Hospital, Osvaldo Hidalgo Leyva, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Holguin, “Octavio de La Concepcion” Hospital, Andres Andres Matos, MD. 1st Degree Specialist in Pediatrics, 1st Degree Specialist in Intensive Care

Granma, “Padiatrico de Bayamo” Hospital, Glenis Morales Torres, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Santiago de Cuba, “Infantil Sur” Hospital, Carlos Ascanio Rodriguez, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Santiago de Cuba, “Infantil Norte” Hospital, Anisleydis Hodelin Taquechel, MD. 1st Degree Specialist in Intensive Medicine and Emergency

Camaguey, “Eduardo Agramonte” Pediatric Hospital, Arianna Sugranes Montalvan, MD. Specialist in Intensive Medicine and Emergency

Guantanamo, “Pedro Agustin Pérez” Pediatric Hospital, Reynaldo Delgado Ravelo, MD. 2nd Degree Specialist in Pediatrics. Diploma in Intensive Care

Research ethics committees:

“Pepe Portillo” hospital, 19/12/2016

“Angel Arturo Aballi” hospital, 06/02/2017

“Juan Manuel Marquez” hospital, 12/04/2017

“Eduardo Agramonte” pediatric hospital, 19/03/2017

“Eliseo Noel Camacho” hospital, 18/01/2017

“Infantil Sur” hospital, 22/11/2016

“Infantil Norte” hospital, 30/11/2016

“Pedro Agustin Perez” pediatric hospital, 10/03/2017

“Padiatrico de Bayamo” hospital, 19/01/2017

“Octavio de La Concepcion” hospital, 13/02/2017

“Martires de Las Tunas” hospital, 28/11/2016

“Jose Luis Miranda” hospital, 21/11/2016

“Jose Marti” hospital, 28/12/2016

“Paquito Gonzalez” hospital, 12/01/2017

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

02/10/2017

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:

Acute Respiratory Distress Syndrome (ARDS)

Health condition(s) code:

Respiratory Distress Syndrome, Adult

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Health condition keyword:

Pediatrics

Intervention(s):

Study group: Surfacen + Conventional oxygenation and mechanical ventilation. Patient will receive 100 mg (4 mL) of Surfacen by endotracheal infusion (instillation through a catheter), every eight hours for three days, no more than nine doses.

Intervention code:

Pulmonary Surfactants

Instillation, Drug

Intubation, Intratracheal

Oxygen Inhalation Therapy

Respiration, Artificial

Intervention keyword:

Surfacen

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):

Serious Adverse Events (AE) with a causal relationship with product use (AE classified as "serious / serious" with a causal relationship classified as "very likely" or "likely"). Measurement time: Since the first dose until eight hours after the last dose.

Key secondary outcomes:

Related to safety. 1- Adverse events-AE (Type of AE (description of de event), Time between administration and appearance of AE (hours, minutes or days), duration of AE (days and hours and, minutes if it is less than 24 hours), Severity of AE (Serious, Non-serious), Intensity of AE (Mild, Moderate, Severe), Causal relationship (Very likely/certain, Likely, Possible, Unlikely, Unrelated, non-evaluable/unclassificable, according to 45/2007 CECMED, Cuban regulatory authority), Attitude followed by the appearance of the AE (Temporal Interruption, Definitive Interruption, Not any change), Treatment of AE (Treatment indicated to counteract the AE will be carried out), Result of AE (Reversible effect, Irreversible effect, Death, Loss of the patient´s follow-up), SURFACEN batch (number of the batch)). Measurement time: Since the first dose until eight hours after the last dose. Related to effectiveness. 2-Acute Respiratory Distress Syndrome in Pediatrics-ARDSP (Light, Moderate, Severe). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. Gasometry values 3- PAO2 (numeric value obtained using a gasometer). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 4- PCO2 (numeric value obtained using a gasometer). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 5- PaO2/FiO2 (numeric value obtained using a gasometer). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. Ventilation parameters 6- Type of ventilation (Invasive ventilation, Non-invasive ventilation). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 7- Ventilatory modality (Control volume, Control pressure, Control volume regulated by pressure). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 8- Oxygenation index-OI (Numerical value calculated by the formula: Mean pressure of the path area x FiO2 x 100 / PaO2). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. Clinical variables: 9- Pulse saturometry (Numerical value obtained from the pulse oximeters). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 10- Blood pressure-BP (numerical value in mm Hg). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 11- Heart rate-HR (heartbeats per minutes). Measurement time: baseline and, one hour after the administrations: 1, 3, 4, 6, 7 and 9 of product. 12- Presence or absence of inflammatory infiltrates in the lung fields (Improvement, Stability, Worsening). Measurement time: daily for treatment and, day 5 Hospital indicators 13- Length of Pediatrics Intensive Care Unit-PICU stay (number of days since admission until discharge from PICU).Measurement time: at discharge of PICU. 14- Length of mechanical ventilation (Number of days from patient is ventilated mechanically until discharge the ventilator support). Measurement time: at discharge the ventilator support. Mortality 15- Patient status (Alive, Death). Measurement 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:

28 days

Maximum age:

18 years

Inclusion criteria:

1. Presence of the Acute Respiratory Distress Syndrome in Pediatrics (ARDSP) in the first seven days of being diagnosed, according to the following criteria: - Origin of edema: A pulmonary failure not related to a heart failure or an overload of intravenous fluids. - Thorax Xr: Presence of new inflammatory infiltrates related to an acute pulmonary disease; bilateral images are not essential. - Oxygenation: Patient ventilated in a non-invasive way: P/F ≤ 300 mm Hg; S/F ≤ 264 mm Hg - Oxygenation: Patient ventilated in an invasive way: Mild: 4 ≤ 10 <8; 5 ≤ OSI <7.5 Moderate: 8 ≤ 10 <16; 7.5 ≤ OSI <12.3 Severe: IO ≥ 16; OSI ≥ 12.3 2. Patients whose parents or legal guardians give their written consent to participate in the study. 3. Age between 28 days and 18 years

Exclusion criteria:

Patients with congenital heart disease with increased pulmonary flow (interventricular communication, atrial septal defect, persistence of ductus arteriosus, pulmonary stenosis, coarctation of aorta, aortic stenosis, tetralogy of Fallot, transposition of large vessels, and tricuspid atresia)

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:

193

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

Middle Name:

Last Name:

Barrese Perez

Specialty:

Bachelor Degree in Pharmaceutical Sciences, Master in Clinical Pharmacy. Clinical Research Assistant

Affiliation:

National Coordinator Center for Clinical Trials (CENCEC)

Postal Address:

Calle 5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164225, +53-72164226, +53-72048742

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:

Valentin

Middle Name:

Santiago

Last Name:

Rodriguez Moya

Specialty:

1st Degree Specialist in Pediatrics. 2nd Degree Specialist in Pediatric Intensive Medicine. Assistant Professor

Affiliation:

Teaching Community Clinic Ignacio Agramonte Loynaz, Camaguey

Postal Address:

Cornelio Porro esquina a 3ra. Camaguey

City:

Camagüey

País:

Cuba

Zip Code:

70100

Telephone:

+53-32336294, +53-32336275

Email :

mrmoya@finlay.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:

RPCEC00000253

Date of Registration in Primary Registry:

29/09/2017

Record Verification Date:

2017/09/29

Next update date:

2018/09/29

Link to the spanish version:

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Proceso de Registro

Safety and effectiveness of SURFACEN® combined with the conventional therapy, in the treatment of ARDS in pediatrics. National extension

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