RecruitingNCT07193771

Altitude and Outcomes in Pediatric ARDS: A Multicenter Study

Evaluation of Altitude as an Independent Risk Factor for Mortality in Pediatric Acute Respiratory Distress Syndrome: Influence of Oxygenation, Ventilation, and Hospital Structure in a Multicenter Observational Study.


Sponsor

Latin American Pediatric Collaborative Network

Enrollment

1,600 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

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 respiratory distress syndrome (PARDS). Data on demographics, physiology, and hospital structure will be collected from PICUs located at different altitudes worldwide. The study aims to identify gaps in PARDS management and provide recommendations adapted to diverse resource settings.


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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).

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Interventions

OTHERGeographic Altitude

Participants are grouped according to the altitude of the pediatric intensive care unit (PICU) where they are admitted: low altitude (0-1500 m), intermediate altitude (1501-2500 m), high altitude (2501-3500 m), and very high altitude (\>3500 m). Altitude is treated as the primary exposure variable. No therapeutic intervention is administered as part of this study.


Locations(11)

Hospital del Niño Sor Teresa Huarte Tama

Sucre, Chuquisaca Department, Bolivia

Clinica Indisa

Santiago, Chile

Hospital Universitario Clinica San Rafael

Bogotá, DC, Colombia

Sociedad de Cirugia de Bogota Hospital de San Jose

Bogotá, DC, Colombia

Fundación HOMI

Bogotá, DC, Colombia

Fundacion Hospital Infantil Los Angeles

Pasto, Departamento de Nariño, Colombia

Clínica UROS S.A

Neiva, Huila Department, Colombia

LaCardio

Bogotá, Colombia

Hospital Nacional Adolfo Guevara Velasco

Cusco, Peru

Centro Hospitalario Pereira Rossell

Montevideo, Montevideo Department, Uruguay

Círculo Católico

Montevideo, Uruguay

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NCT07193771


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