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

Phase 4

Recruiting

• Conditions: Pediatrics; Lung Diseases; Respiratory Distress Syndrome, Adult; Respiratory Tract Diseases; Acute Respiratory Distress Syndrome (ARDS); Respiration Disorders

• Registration Number: RPCEC00000253
• Lead Sponsor: ational Center for Animal and Plant Health (CENSA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-29
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 193

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br><br>