NCT07193771

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Nov 2025

Typical duration for all trials

Geographic Reach
5 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Nov 2025Mar 2028

First Submitted

Initial submission to the registry

September 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

September 18, 2025

Last Update Submit

May 29, 2026

Conditions

Respiratory Distress Syndrome, PediatricAltitude HypoxiaHigh Altitude Effects

Outcome Measures

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.

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

Secondary Outcomes (3)

  • New morbidity at hospital discharge

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

  • Ventilator-free days at 28 days.

    28 days after initiation of invasive mechanical ventilation

  • ICU-free days at 28 days.

    28 days after ICU admission

Study Arms (4)

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

Geographic AltitudeOTHER

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
High Altitude PICUsIntermediate Altitude PICUsLow Altitude PICUsVery High Altitude PICUs

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

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

Related Publications (4)

  • 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.

    PMID: 40784821RESULT

  • 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.

    PMID: 25647235RESULT

  • 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.

    PMID: 39882326RESULT

  • 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.

    PMID: 31582181RESULT

Related Links

MeSH Terms

Conditions

Respiratory Distress SyndromeAltitude Sickness

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

PABLO VASQUEZ-HOYOS, MD, MSc

CONTACT

573187172029pablovasquezmd@gmail.com

SEBASTIAN GONZALEZ-DAMBRAUSKAS, MD

CONTACT

59899585225sgdambrauskas@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2025

First Posted

September 26, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)BO(4)CO(11)PE(2)UR(2)