Effect and Safety of the nebulized surfactant SURFACEN® in the treatment of broncho-obstructive syndrome in children. Exploratory Phase

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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:

Exploration of the effect and safety of the nebulized surfactant SURFACEN® compared and combined with the conventional therapy in the treatment of broncho-obstructive syndrome in children in Progressive Care Units (PCUs)

Secondary indentifying numbers:

PNBCF9523

Issuing authority of the secondary identifying numbers:

National Center for Animal and Plant Health (CENSA)

Source(s) of monetary or material support:

National Program for Biotechnology, Pharmaceutical Industry and Medical Technology

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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Berta

Midle name:

Lidia

Last name:

Acevedo Castro

Medical Specialty :

First Degree Specialist in Pediatrics. Second Degree Specialist in Intensive Care and Emergency Medicine

Affiliation:

Juan Manuel Marquez Pediatric Hospital

Postal address:

Avenida 31 e/ 76 y 100. Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-56956542

+53-52091607

Email address:

drabertica@gmail.com

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, Juan Manuel Marquez Pediatric Hospital, Janet Moreira Barrio, MD. First Degree Specialist in Intensive Care and Emergency Medicine

Havana, Centro Habana Pediatric Hospital, Anne Mare Monier Badia, MD. First Degree Specialist in Pediatrics and Diploma in Intensive Care

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

22/08/2024

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:

Broncho-obstructive syndrome (BOS) in children

Intervention(s):

Group A (Experimental): Conventional therapy combined with SURFACEN®. SURFACEN® will be received for 3 days, by inhalation, at a dose of 3mg/kg every 8 hours with a maximum dose limit of 100mg. In patients who, after receiving six doses (48 hours of treatment), show, according to the modified Tal score, a severity category of BOS lower than that at the time of inclusion in the study, and the specialist considers, treatment with surfactant may be concluded under the criterion of responder patient. Group B (Control): Conventional therapy. Patients will receive only the conventional treatment protocolized in in Progressive Care Units (PCUs) for BOS.

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):

Severity of the Broncho-obstructive syndrome-BOS (Modified Tal Score (MTS): mild (≤ 5 points), moderate (≥ 6 and ≤ 8 points) and severe (≥ 9 and ≤ 12 points)). Measurement time: At baseline and, every 8 hours, after each administration of SURFACEN® (group A), always before receiving the next dose; simulating these times in group B.

Key secondary outcomes:

1. Clinical signs and symptoms (Heart rate-HR(value in lat/min)), Respiratory rate-RR (value in resp/min), Apnea crisis (Yes, No), Wheezing (Yes, No), Intercostal retraction (Yes, No)). Measurement time: At baseline and, every 8 hours, after each administration of SURFACEN® (group A), always before receiving the next dose; simulating these times in group B. 2. Oxygenation parameters (PCO2, pH, Oxygen therapy, SpO2). Measurement time: At baseline and, every 8 hours, after each administration of SURFACEN® (group A), always before receiving the next dose; simulating these times in group B. 3. Hospital indicators 3.1 Days of stay at the Progressive Care Units-PCU (Days from admission to PCU until discharge the PCU). Measurement time: At discharge from PCU 3.2 Days at the hospital (Days from admission to the hospital until discharge hospitality discharge). Measurement time: At hospital discharge. 4. Mortality indicators 4.1 Patient status at discharge (Alive, Deceased). Measurement time: At PCU discharge 4.2 Patient status at day 28 (Alive, Deceased and, cause of death in case of death). Measurement time: Day 28 5. Adverse Events-AE (Type of AE (description of the AE); Severity (Serious, not serious); Intensity (Mild, Moderate, Severe); Duration (Time elapsed between the start and end of the AE); Causality relationship (Very likely/Certain, probable, Probable, Possible, Improbable, Unrelated, Not assessable/unclassifiable); Attitude towards treatment (No change, Temporary interruption, Definitive interruption); Treatment of the AE (name of the indicated treatment, dose, route of administration, start and end date of the treatment); Outcome (It recovers, Enhances, Persists, Leave squeals, Death)). Measurement time: From the first dose of SURFACEN® (group A) until to eight hours after the last dose; simulating these times in group B from the randomization patient until three days later (72 hours).

Selection criterias

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

Gender:

Male/Female

Minimum age:

29 days

Maximum age:

5 years

Inclusion criteria:

1. Patient between 29 days old and 5 years old. 2. Patient whose parents or legal tutors give their written consent to participate in the study.

Exclusion criteria:

1. Patient requiring invasive mechanical ventilation. 2. Patient with known hypersensitivity to SURFACEN® or another component of the formulation. 3. Patient who has participated in another clinical trial in the last six months or who is participating in another clinical trial. 4. Patient receiving treatment with another product under research.

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:

N/A

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

Specialty:

Pharmaceutical Sciences Degree. Master in Clinical Pharmacy

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

5ta A e/60 y 62 Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164226, +53-72164225

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:

Berta

Middle Name:

Lidia

Last Name:

Acevedo Castro

Specialty:

First Degree Specialist in Pediatrics. Second Degree Specialist in Intensive Care and Emergency Medicine

Affiliation:

Juan Manuel Marquez Pediatric Hospital

Postal Address:

Avenida 31 e/ 76 y 100 Marianao

City:

Havana

País:

Cuba

Zip Code:

11500

Telephone:

+53-56956542, +53-52091607

Email :

drabertica@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Juan Manuel Marquez Pediatric Hospital

Centro Habana Pediatric Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

26/04/2024

20/05/2024

Postal address of Ethic Committee :

Avenida 31 e/ 76 y 100. Marianao. ZC: 11500, Havana. Cuba

Calle Benjumeda esquina Morales. Cerro. ZC: 10600, Havana. Cuba

Telephone:

+53-72606140

+53-78775555

Correo electrónico:

mavaldes@infomed.sld.cu

pilarmacuna@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

22/03/2025

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:

RPCEC00000442

Date of Registration in Primary Registry:

30/05/2024

Record Verification Date:

2024/05/30

Next update date:

2025/05/30

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Effect and Safety of the nebulized surfactant SURFACEN® in the treatment of broncho-obstructive syndrome in children. Exploratory Phase

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