Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
NCT ID: NCT07193771
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1600 participants
OBSERVATIONAL
2025-11-01
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome
NCT03585582
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
NCT05388708
Long-term Impact of COVID-19 Among COVID-19 Patients With Acute Respiratory Distress Syndrome in Brazil
NCT05225194
Arterial pH Selectively Predicts Intensive Care Unit Transfer From the Emergency Department in Obese Patients With Acute Dyspnea
NCT03239730
Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study
NCT02836444
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes between 0-1500 meters above sea level.
Geographic 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.
Intermediate Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes between 1501-2500 meters above sea level.
Geographic 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.
High Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes between 2501-3500 meters above sea level.
Geographic 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.
Very High Altitude PICUs
Children with PARDS admitted to pediatric intensive care units located at altitudes above 3500 meters above sea level.
Geographic 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Geographic 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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).
1 Month
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Nacional de Colombia
OTHER
Fundación Universitaria de Ciencias de la Salud
OTHER
Latin American Pediatric Collaborative Network
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinica Indisa
Santiago, , Chile
Hospital Universitario Clinica San Rafael
Bogotá, DC, Colombia
Sociedad de Cirugia de Bogota Hospital de San Jose
Bogotá, DC, Colombia
Fundación HOMI
Bogotá, DC, Colombia
Fundacion Hospital Infantil Los Angeles
Pasto, Departamento de Nariño, Colombia
Clínica UROS S.A
Neiva, Huila Department, Colombia
Centro Hospitalario Pereira Rossell
Montevideo, Montevideo Department, Uruguay
Círculo Católico
Montevideo, , Uruguay
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LARED-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.