Actively Recruiting

Age: 1Month - 18Years
All Genders
ID07193771

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

Led by Latin American Pediatric Collaborative Network · Updated on 2026-06-02

1600

Participants Needed

20

Research Sites

17 weeks

Total Duration

On this page

Sponsors

L

Latin American Pediatric Collaborative Network

Lead Sponsor

U

Universidad Nacional de Colombia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how geographic altitude and the availability of critical care resources affect health outcomes in children with pediatric acute respiratory distress syndrome (PARDS). This multicenter observational study collects data on patient demographics, physiology, and hospital structures from pediatric intensive care units (PICUs) located at various altitudes worldwide. The goal is to identify differences in PARDS management and develop recommendations tailored to diverse healthcare settings. Participants are grouped based on the altitude of the PICU where they receive care: low altitude (0-1500 meters), intermediate altitude (1501-2500 meters), high altitude (2501-3500 meters), and very high altitude (above 3500 meters). No treatments are given as part of the study; instead, the focus is on observing and analyzing existing care practices and patient outcomes across these different altitude groups. Throughout the study, researchers will collect clinical, physiological, and institutional data from children admitted to PICUs requiring mechanical ventilation and diagnosed with PARDS. They will measure key outcomes such as in-hospital mortality up to 90 days, new health issues at discharge, ventilator-free days, and ICU-free days within 28 days. The study aims to provide evidence to improve critical care practices for children with PARDS globally. Participation may last until hospital discharge or up to 90 days after PICU admission.

CONDITIONS

Brief Title

Altitude and Outcomes in Pediatric ARDS: A Multicenter Study

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 1 month (corrected gestational age) and 18 years
  • Admission to a pediatric intensive care unit or facility caring for mechanically ventilated children
  • Requirement of invasive mechanical ventilation
  • Diagnosis of pediatric acute respiratory distress syndrome (PARDS) according to PALICC criteria, confirmed within 24 hours before or after intubation
Not Eligible

You will not qualify if you...

  • Active perinatal lung disease such as neonatal respiratory distress syndrome, pulmonary hemorrhage, persistent pulmonary hypertension of the newborn, early bronchopulmonary dysplasia, or meconium aspiration
  • Received extracorporeal membrane oxygenation (ECMO) before or within the first 24 hours of PARDS diagnosis
  • Pre-established limitation of therapeutic effort orders or palliative care directives before invasive mechanical ventilation
  • Readmission to the pediatric intensive care unit during the study period (only first episode included)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 90 days from PICU admission until hospital discharge

Participants who undergo routine care in pediatric intensive care units at various altitudes are observed to study the impact of altitude and hospital resources on outcomes in pediatric acute respiratory distress syndrome (PARDS).

Trial Site Locations

Total: 20 locations

1

Hospital del Niño Sor Teresa Huarte Tama

Sucre, Chuquisaca Department, Bolivia

Actively Recruiting

2

Hospital del Norte - El Alto

La Paz, La Paz Department, Bolivia

Actively Recruiting

3

Hospital Daniel Brancamonte

Potosí, Potosí Department, Bolivia

Actively Recruiting

4

Hospital Regional San Juan de Dios

Tarija, Tarija Department, Bolivia

Actively Recruiting

5

Clinica Indisa

Santiago, Chile

Actively Recruiting

6

Hospital Universitario Clinica San Rafael

Bogotá, DC, Colombia, 110411

Actively Recruiting

7

Sociedad de Cirugia de Bogota Hospital de San Jose

Bogotá, DC, Colombia, 110421

Actively Recruiting

8

Fundación HOMI

Bogotá, DC, Colombia, 111411

Actively Recruiting

9

Hospital Militar Central de Bogotá

Bogotá, DC, Colombia

Actively Recruiting

10

Hospital Santa Clara

Bogotá, DC, Colombia

Actively Recruiting

11

Hospital Universitario San Ignacio

Bogotá, DC, Colombia

Actively Recruiting

12

Los Cobos Medical Center

Bogotá, DC, Colombia

Actively Recruiting

13

Fundacion Hospital Infantil Los Angeles

Pasto, Departamento de Nariño, Colombia, 520002

Actively Recruiting

14

Clínica UROS S.A

Neiva, Huila Department, Colombia, 410010

Actively Recruiting

15

Fundación Valle de Lili

Cali, Valle del Cauca Department, Colombia

Not Yet Recruiting

16

LaCardio

Bogotá, Colombia, 110131

Not Yet Recruiting

17

Hospital de Emergencias Pediatricas

Lima, Lima Province, Peru

Actively Recruiting

18

Hospital Nacional Adolfo Guevara Velasco

Cusco, Peru

Actively Recruiting

19

Centro Hospitalario Pereira Rossell

Montevideo, Montevideo Department, Uruguay, 11600

Actively Recruiting

20

Círculo Católico

Montevideo, Uruguay

Actively Recruiting

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Research Team

P

PABLO VASQUEZ-HOYOS, MD, MSc

S

SEBASTIAN GONZALEZ-DAMBRAUSKAS, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Definitions and consensus recommendations on critical care medicine at altitude from the Expert Committee on Critical Care Medicine at altitude of the Pan-American and Iberian Federation of Critical Care Medicine and Intensive Care.

Amilcar Tinoco-Solórzano, Adrian Avila-Hilari, Manuel Luis Avellanas-Chavala...

https://pubmed.ncbi.nlm.nih.gov/40784821

Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference.

Pediatric Acute Lung Injury Consensus Conference Group

https://pubmed.ncbi.nlm.nih.gov/25647235

Inflammation severity, rather than respiratory failure, is strongly associated with mortality of ARDS patients in high-altitude ICUs.

Daniel Molano-Franco, Joan Ramon Masclans Enviz, Antonio Viruez-Soto...

https://pubmed.ncbi.nlm.nih.gov/39882326

Hospital Mortality and Effect of Adjusting PaO2/FiO2 According to Altitude Above the Sea Level in Acclimatized Patients Undergoing Invasive Mechanical Ventilation. A Multicenter Study.

Manuel Jibaja, Guillermo Ortiz-Ruiz, Fernanda García...

https://pubmed.ncbi.nlm.nih.gov/31582181