Status:
RECRUITING
Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
Lead Sponsor:
Latin American Pediatric Collaborative Network
Collaborating Sponsors:
Universidad Nacional de Colombia
Fundación Universitaria de Ciencias de la Salud
Conditions:
Respiratory Distress Syndrome, Pediatric
Altitude Hypoxia
Eligibility:
All Genders
1-18 years
Brief Summary
This multicenter observational study will evaluate the association between geographic altitude, availability of critical care resources, and clinical outcomes in children with pediatric acute respirat...
Detailed Description
Pediatric acute respiratory distress syndrome (PARDS) is a major cause of admission and mortality in pediatric intensive care units (PICUs). In high-altitude regions, hypoxemia may be exacerbated, com...
Eligibility Criteria
Inclusion
- Age between 1 month (corrected gestational age) and 18 years.
- Admission to a pediatric intensive care unit (PICU) or facility where mechanically ventilated children are cared for.
- Requirement of invasive mechanical ventilation.
- Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after endotracheal intubation.
Exclusion
- Patients with active perinatal lung disease (e.g., neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, meconium aspiration).
- Patients who have received extracorporeal membrane oxygenation (ECMO) prior to or within the first 24 hours of PARDS diagnosis.
- Patients with pre-established limitation of therapeutic effort (LTE) orders or palliative care directives documented before the initiation of invasive mechanical ventilation.
- Readmissions to the PICU during the study period (only the first episode per patient will be included).
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT07193771
Start Date
November 1 2025
End Date
March 1 2028
Last Update
January 9 2026
Active Locations (6)
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1
Clinica Indisa
Santiago, Chile
2
Sociedad de Cirugia de Bogota Hospital de San Jose
Bogotá, DC, Colombia, 110421
3
Fundacion Hospital Infantil Los Angeles
Pasto, Departamento de Nariño, Colombia, 520002
4
Clínica UROS S.A
Neiva, Huila Department, Colombia, 410010