How altitude affects outcomes for children with acute respiratory distress
Official title: 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.
Run by Latin American Pediatric Collaborative Network · NCT07193771 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Month to 18 Years |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | Latin American Pediatric Collaborative Network Academic / other |
| Locations | 20 sites (Sucre, Chuquisaca Department and 19 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 2027 |
| Study ends | March 2028 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07193771 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Hospital del Niño Sor Teresa Huarte Tama
Sucre, Chuquisaca Department, Bolivia Recruiting -
Hospital del Norte - El Alto
La Paz, La Paz Department, Bolivia Recruiting -
Hospital Daniel Brancamonte
Potosí, Potosí Department, Bolivia Recruiting -
Hospital Regional San Juan de Dios
Tarija, Tarija Department, Bolivia Recruiting -
Clinica Indisa
Santiago, Chile Recruiting -
Hospital Universitario Clinica San Rafael
Bogotá, Dc, Colombia Recruiting
Show 14 more locations
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Sociedad de Cirugia de Bogota Hospital de San Jose
Bogotá, Dc, Colombia Recruiting -
Fundación HOMI
Bogotá, Dc, Colombia Recruiting -
Hospital Militar Central de Bogotá
Bogotá, Dc, Colombia Recruiting -
Hospital Santa Clara
Bogotá, Dc, Colombia Recruiting -
Hospital Universitario San Ignacio
Bogotá, Dc, Colombia Recruiting -
Los Cobos Medical Center
Bogotá, Dc, Colombia Recruiting -
Fundacion Hospital Infantil Los Angeles
Pasto, Departamento de Nariño, Colombia Recruiting -
Clínica UROS S.A
Neiva, Huila Department, Colombia Recruiting -
Hospital de Emergencias Pediatricas
Lima, Lima Province, Peru Recruiting -
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru Recruiting -
Centro Hospitalario Pereira Rossell
Montevideo, Montevideo Department, Uruguay Recruiting -
Círculo Católico
Montevideo, Uruguay Recruiting -
Fundación Valle de Lili
Cali, Valle del Cauca Department, Colombia Not yet recruiting -
LaCardio
Bogotá, Colombia Not yet recruiting
Study contacts
- Study coordinator: PABLO VASQUEZ-HOYOS, MD, MSc
- Email: pablovasquezmd@gmail.com
- Phone: 573187172029
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.