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

ational Center for Animal and Plant Health (CENSA)0 个研究点目标入组 193 人开始时间: 2017年9月29日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•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

•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)

发起方

ational Center for Animal and Plant Health (CENSA)