How altitude affects outcomes for children with acute respiratory distress

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.

This project will see if higher altitude and differences in hospital critical-care resources change outcomes for children (1 month–18 years) with PARDS who need invasive mechanical ventilation.

Quick facts

• Study type: Observational
• Enrollment: 1600 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Latin American Pediatric Collaborative Network (other)
• Locations: 11 sites (Sucre, Chuquisaca Department and 10 other locations)
• Trial ID: NCT07193771 on ClinicalTrials.gov

What this trial studies

This multicenter observational study will collect prospective and retrospective clinical, physiological, and institutional data from PICUs located at different geographic altitudes. Investigators will record patient demographics, oxygenation and ventilation metrics, and details about available equipment and trained staff at each site. Analyses will examine how altitude and resource availability interact with oxygenation/ventilation parameters to influence outcomes such as mortality, duration of mechanical ventilation, and complications. The goal is to identify management gaps and produce context-specific recommendations to improve PARDS care across varied resource settings.

Who should consider this trial

Good fit: Children aged 1 month (corrected gestational age) to 18 years admitted to a PICU who require invasive mechanical ventilation and meet PALICC criteria for PARDS are the intended participants.

Not a fit: Children with active perinatal lung disease, those who received ECMO before or within 24 hours of PARDS diagnosis, patients with pre-established palliative or limitation-of-therapy orders, and PICU readmissions are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the findings could inform altitude- and resource-adapted guidelines that improve care and reduce outcome disparities for children with PARDS.

How similar studies have performed: Smaller adult and pediatric reports have suggested altitude and resource differences can affect hypoxemia and outcomes, but large multicenter pediatric data are limited, making this approach relatively novel for PARDS.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Sucre, Chuquisaca Department and 10 other locations

• Hospital del Niño Sor Teresa Huarte Tama — Sucre, Chuquisaca Department, Bolivia (RECRUITING)
• Clinica Indisa — Santiago, Chile (RECRUITING)
• Hospital Universitario Clinica San Rafael — Bogotá, DC, Colombia (RECRUITING)
• Sociedad de Cirugia de Bogota Hospital de San Jose — Bogotá, DC, Colombia (RECRUITING)
• Fundación HOMI — Bogotá, DC, Colombia (RECRUITING)
• Fundacion Hospital Infantil Los Angeles — Pasto, Departamento de Nariño, Colombia (RECRUITING)
• Clínica UROS S.A — Neiva, Huila Department, Colombia (RECRUITING)
• LaCardio — Bogotá, Colombia (NOT_YET_RECRUITING)
• Hospital Nacional Adolfo Guevara Velasco — Cusco, Peru (RECRUITING)
• Centro Hospitalario Pereira Rossell — Montevideo, Montevideo Department, Uruguay (RECRUITING)
• Círculo Católico — Montevideo, Uruguay (RECRUITING)

Study contacts

• Study coordinator: PABLO VASQUEZ-HOYOS, MD, MSc

Conditions: Respiratory Distress Syndrome, Pediatric, Altitude Hypoxia, High Altitude Effects