Evaluation of Altitude as an Independent Risk Factor for Mortality in Pediatric Acute Respiratory Distress Syndrome Using Oxygenation, Ventilation, and Hospital Structure Data in a Multicenter Observational Study
Led by Latin American Pediatric Collaborative Network · Updated on 2026-06-02
1600
Participants Needed
20
Research Sites
17 weeks
Total Duration
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Brief Title
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Sponsors
L
Latin American Pediatric Collaborative Network
Lead Sponsor
U
Universidad Nacional de Colombia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how geographic altitude and the availability of critical care resources affect health outcomes in children with pediatric acute respiratory distress syndrome (PARDS). This multicenter observational study collects data on patient demographics, physiology, and hospital structures from pediatric intensive care units (PICUs) located at various altitudes worldwide. The goal is to identify differences in PARDS management and develop recommendations tailored to diverse healthcare settings.
Participants are grouped based on the altitude of the PICU where they receive care: low altitude (0-1500 meters), intermediate altitude (1501-2500 meters), high altitude (2501-3500 meters), and very high altitude (above 3500 meters). No treatments are given as part of the study; instead, the focus is on observing and analyzing existing care practices and patient outcomes across these different altitude groups.
Throughout the study, researchers will collect clinical, physiological, and institutional data from children admitted to PICUs requiring mechanical ventilation and diagnosed with PARDS. They will measure key outcomes such as in-hospital mortality up to 90 days, new health issues at discharge, ventilator-free days, and ICU-free days within 28 days. The study aims to provide evidence to improve critical care practices for children with PARDS globally. Participation may last until hospital discharge or up to 90 days after PICU admission.
CONDITIONS
Brief Title
Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
Who Can Participate
Age: 1Month - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Age between 1 month (corrected gestational age) and 18 years
Admission to a pediatric intensive care unit or facility caring for mechanically ventilated children
Requirement of invasive mechanical ventilation
Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after intubation
You will not qualify if you...
Active perinatal lung disease such as neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, or meconium aspiration
Received extracorporeal membrane oxygenation (ECMO) before or within the first 24 hours of PARDS diagnosis
Pre-established limitation of therapeutic effort orders or palliative care directives before invasive mechanical ventilation
Readmission to the pediatric intensive care unit during the study period (only first episode included)
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 90 days from PICU admission until hospital discharge
Participants who undergo routine care in pediatric intensive care units at various altitudes are observed to study the impact of altitude and hospital resources on outcomes in pediatric acute respiratory distress syndrome (PARDS).
Trial Site Locations
Total: 20 locations
1
Hospital del Niño Sor Teresa Huarte Tama
Sucre, Chuquisaca Department, Bolivia
Actively Recruiting
2
Hospital del Norte - El Alto
La Paz, La Paz Department, Bolivia
Actively Recruiting
3
Hospital Daniel Brancamonte
Potosí, Potosí Department, Bolivia
Actively Recruiting
4
Hospital Regional San Juan de Dios
Tarija, Tarija Department, Bolivia
Actively Recruiting
5
Clinica Indisa
Santiago, Chile
Actively Recruiting
6
Hospital Universitario Clinica San Rafael
Bogotá, DC, Colombia, 110411
Actively Recruiting
7
Sociedad de Cirugia de Bogota Hospital de San Jose
Definitions and consensus recommendations on critical care medicine at altitude from the Expert Committee on Critical Care Medicine at altitude of the Pan-American and Iberian Federation of Critical Care Medicine and Intensive Care.
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Manuel Jibaja, Guillermo Ortiz-Ruiz, Fernanda García...