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NCT Number: NCT07193771

Altitude and Outcomes in Pediatric ARDS: A Multicenter Study

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Niño Sor Teresa Huarte Tama, Sucre, Chuquisaca Department, Bolivia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Geographic Altitude

Other

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.

Other names: Altitude Exposure

Primary outcomes

  1. In-hospital mortality

    Time frame: From 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 outcomes

  1. New morbidity at hospital discharge

    Time frame: From PICU admission until hospital discharge (up to 90 days)

    Presence of new functional morbidity measured using Functional Status Score greater than 2.

  2. Ventilator-free days at 28 days.

    Time frame: 28 days after initiation of invasive mechanical ventilation

    Defined 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.

  3. ICU-free days at 28 days.

    Time frame: 28 days after ICU admission

    Defined 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.

Study contacts

Contact information is provided by the study sponsor or research team.

PABLO VASQUEZ-HOYOS, MD, MSc

CONTACT

[email protected]

573187172029

SEBASTIAN GONZALEZ-DAMBRAUSKAS, MD

CONTACT

[email protected]

59899585225

Sponsors and collaborators

Lead sponsor

Latin American Pediatric Collaborative Network

Other

Collaborators

  • Fundación Universitaria de Ciencias de la Salud
  • Universidad Nacional de Colombia

Registry information

Official study 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.

Acronym: LARed-ALT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 26, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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