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RecruitingNCT07193771LARed-ALTUpdated Jun 2, 2026

Altitude and Outcomes in Pediatric ARDS: A Multicenter Study

An observational study in Respiratory Distress Syndrome, Pediatric, Altitude Hypoxia and High Altitude Effects, sponsored by Latin American Pediatric Collaborative Network. Recruiting at 20 sites in 5 countries. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Latin American Pediatric Collaborative Network · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,600
Ages
1 Month to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Respiratory Distress Syndrome, Pediatric
  • Altitude Hypoxia
  • High Altitude Effects
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In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

This is the only study on the registry with Latin American Pediatric Collaborative Network as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Mechanically ventilated children and adolescents (1 month-18 years) admitted to PICUs at different altitudes worldwide, who fulfill PALICC criteria for PARDS within 24 hours before or after intubation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Low Altitude PICUs

    Children with PARDS admitted to pediatric intensive care units located at altitudes between 0-1500 meters above sea level.

    Other: Geographic Altitude

  • Intermediate Altitude PICUs

    Children with PARDS admitted to pediatric intensive care units located at altitudes between 1501-2500 meters above sea level.

    Other: Geographic Altitude

  • High Altitude PICUs

    Children with PARDS admitted to pediatric intensive care units located at altitudes between 2501-3500 meters above sea level.

    Other: Geographic Altitude

  • Very High Altitude PICUs

    Children with PARDS admitted to pediatric intensive care units located at altitudes above 3500 meters above sea level.

    Other: Geographic Altitude

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.

    Also known as: Altitude Exposure

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What researchers measure

Primary outcomes

  1. In-hospital mortality

    Proportion of patients with PARDS who die during hospitalization. Mortality is defined as death during the same hospitalization period in which PARDS was diagnosed.

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

Secondary outcomes

  1. New morbidity at hospital discharge

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

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

  2. Ventilator-free days at 28 days.

    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.

    Time frame: 28 days after initiation of invasive mechanical ventilation

  3. ICU-free days at 28 days.

    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.

    Time frame: 28 days after ICU admission

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Study locations

18 of 20 sites recruiting
  • 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 110411, Colombia
    Recruiting
  • Sociedad de Cirugia de Bogota Hospital de San Jose
    Bogotá, DC 110421, Colombia
    Recruiting
  • Fundación HOMI
    Bogotá, DC 111411, 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 520002, Colombia
    Recruiting
  • Clínica UROS S.A
    Neiva, Huila Department 410010, Colombia
    Recruiting
  • Fundación Valle de Lili
    Cali, Valle del Cauca Department, Colombia
    Not yet recruiting
  • LaCardio
    Bogotá, 110131, Colombia
    Not yet 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 11600, Uruguay
    Recruiting
  • Círculo Católico
    Montevideo, Uruguay
    Recruiting
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References and documents

Publications

  • Tinoco-Solorzano A, Avila-Hilari A, Avellanas-Chavala ML, Montelongo FJ, Velez-Paez J, Nieto Estrada V, Viruez Soto A, Molano Franco D, Castelo Tamayo E, Granda Luna I, Salazar Mendoza A, Mamani Cruz L, Galindo Ayala J, Vasquez-Hoyos P, Maldonado Coronel F, Huanca Payehuanca R, Sanchez Medina JR. 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. Med Intensiva (Engl Ed). 2025 Oct;49(10):502256. doi: 10.1016/j.medine.2025.502256. Epub 2025 Aug 9. PubMed 40784821 ↗
  • Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350. PubMed 25647235 ↗
  • Molano-Franco D, Masclans Enviz JR, Viruez-Soto A, Gomez M, Rojas H, Beltran E, Nieto V, Aliaga-Raduan F, Iturri P, Arias-Reyes C, Soliz J. Inflammation severity, rather than respiratory failure, is strongly associated with mortality of ARDS patients in high-altitude ICUs. Front Physiol. 2025 Jan 15;15:1520650. doi: 10.3389/fphys.2024.1520650. eCollection 2024. PubMed 39882326 ↗
  • Jibaja M, Ortiz-Ruiz G, Garcia F, Garay-Fernandez M, de Jesus Montelongo F, Martinez J, Viruez JA, Baez-Pravia O, Salazar S, Villacorta-Cordova F, Morales F, Tinoco-Solorzano A, Ibanez Guzman C, Valle Pinheiro B, Zubia-Olaskoaga F, Duenas C, Garcia AL, Cardinal-Fernandez P. 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. Arch Bronconeumol (Engl Ed). 2020 Apr;56(4):218-224. doi: 10.1016/j.arbres.2019.06.024. Epub 2019 Sep 30. English, Spanish. PubMed 31582181 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07193771
Lead sponsor
Latin American Pediatric Collaborative Network
Collaborators
Universidad Nacional de Colombia, Fundación Universitaria de Ciencias de la Salud
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Nov 1, 2025
Primary completion
Nov 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Jun 2, 2026

Study contacts

PABLO VASQUEZ-HOYOS, MD, MSc
Contact
pablovasquezmd@gmail.com
573187172029
SEBASTIAN GONZALEZ-DAMBRAUSKAS, MD
Contact
sgdambrauskas@gmail.com
59899585225

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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