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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07193771
Acronym
LARed-ALT
Enrollment
1600
Registered
2025-09-26
Start date
2025-11-01
Completion date
2028-03-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 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.

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, complicating diagnostic interpretation and clinical decision-making. At the same time, variability in the availability of advanced resources-such as mechanical ventilation modes, monitoring systems, and trained personnel-could significantly influence outcomes. This study will prospectively and retrospectively collect clinical, physiological, and institutional data from pediatric cohorts admitted to PICUs situated at different altitudes worldwide. The analysis will explore how altitude and structural resource differences interact with oxygenation and ventilation parameters to affect patient outcomes. The ultimate goal is to generate evidence that supports context-specific guidelines, reduces inequities in critical care delivery, and strengthens pediatric intensive care practices globally.

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.

Sponsors

Latin American Pediatric Collaborative Network
Lead SponsorOTHER
Universidad Nacional de Colombia
CollaboratorOTHER
Fundación Universitaria de Ciencias de la Salud
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortalityFrom PICU admission until hospital discharge (up to 90 days)Proportion of patients with PARDS who die during hospitalization. Mortality is defined as death during the same hospitalization period in which PARDS was diagnosed.

Secondary

MeasureTime frameDescription
New morbidity at hospital dischargeFrom PICU admission until hospital discharge (up to 90 days)Presence of new functional morbidity measured using Functional Status Score greater than 2.
Ventilator-free days at 28 days.28 days after initiation of invasive mechanical ventilationDefined as the number of days a patient is alive and free from invasive mechanical ventilation during the first 28 days after initiation of ventilation. Patients who die within 28 days of initiation will be assigned a value of 0. For survivors, ventilator-free days will be calculated as 28 minus the total number of days on invasive mechanical ventilation during this period.
ICU-free days at 28 days.28 days after ICU admissionDefined as the number of days a patient is alive and not admitted to the ICU during the first 28 days after ICU admission. Patients who die within 28 days of ICU admission will be assigned a value of 0. For survivors, ICU-free days will be calculated as 28 minus the total number of days spent in the ICU during this period.

Countries

Bolivia, Chile, Colombia, Peru, Uruguay

Contacts

CONTACTPABLO VASQUEZ-HOYOS, MD, MSc
pablovasquezmd@gmail.com573187172029
CONTACTSEBASTIAN GONZALEZ-DAMBRAUSKAS, MD
sgdambrauskas@gmail.com59899585225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026