Acute Respiratory Distress Syndrome (ARDS) Pediatrics
Conditions
Interventions
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 hour
Pulmonary Surfactants
Intubation, Intratracheal
Oxygen Inhalation Therapy
Respiration, Artificial
Surfacen
Sponsors
National Center for Animal and Plant Health (CENSA)
Eligibility
Sex/Gender
All
Age
28 Days to 18 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (Numeric | — |
Countries
Cuba
Contacts
Public ContactYinet Barrese Perez
National Coordinator Center for Clinical Trials (CENCEC)
Outcome results
None listed