Broncho-obstructive syndrome (BOS) in children
Conditions
Interventions
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 pat
Sponsors
National Center for Animal and Plant Health (CENSA)
Eligibility
Sex/Gender
All
Age
29 Days to 5 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Cuba
Contacts
Public ContactYinet Barrese Perez
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed