Respiratory Distress Syndrome, PediatricLARed-ALTNCT07193771
Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
An observational study of Respiratory Distress Syndrome, Pediatric and Altitude Hypoxia, run by Latin American Pediatric Collaborative Network at 20 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiratory Distress Syndrome, Pediatric, Altitude Hypoxia, High Altitude Effects
- What is being tested?
- Geographic Altitude
- How many people
- 1,600 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 1 Nov 2025to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 5 countries
Colombia11 sites, 11 recruiting
- Recruiting
Hospital Universitario Clinica San Rafael
Bogotá, DC, 110411
Jennifer Morantes, MD, +573007763472, jennmorantes@gmail.com
- Recruiting
Sociedad de Cirugia de Bogota Hospital de San Jose
Bogotá, DC, 110421
Pablo Vasquez Hoyos, MD, MSc, 57318717-2029, pvasquez@fucsalud.edu.co
- Recruiting
Fundación HOMI
Bogotá, DC, 111411
Diana Escobar, MD, +573147045321, dpescobars@unal.edu.co
- Recruiting
Hospital Militar Central de Bogotá
Bogotá, DC
Ledys Izquierdo, MD, +573124819193, lizquierdo@homil.gov.co
- Recruiting
Hospital Santa Clara
Bogotá, DC
Ledys Izquierdo, MD, +573124819193, lizquierdo@unal.edu.co
- Recruiting
Hospital Universitario San Ignacio
Bogotá, DC
Deyanira Quiñones, MD, adquinonez@husi.org.co
- Recruiting
Los Cobos Medical Center
Bogotá, DC
Andrea Rodríguez Mayorga, MD, +573142128477, andrerodriguezmayorga@gmail.com
- Not yet recruiting
LaCardio
Bogotá, 110131
Jaime Fernandez Sarmiento, MD, PHD, +573103249002, jaimefe@unisabana.edu.co
- Not yet recruiting
Fundación Valle de Lili
Cali, Valle del Cauca Department
Ruben Lasso, MD, +573008200144, rubenlasso@gmail.com
- Recruiting
Clínica UROS S.A
Neiva, Huila Department, 410010
Ivan Ardila, MD, +573174301866, ivanjoardila@hotmail.com
- Recruiting
Fundacion Hospital Infantil Los Angeles
Pasto, Departamento de Nariño, 520002
Liliana Mazzillo, MD, lilianamazzillo@gmail.com
Bolivia4 sites, 4 recruiting
- Recruiting
Hospital del Norte - El Alto
La Paz, La Paz Department
Ingrid Dávalos, MD, +59175411754, narelita.dz@hotmail.com
- Recruiting
Hospital Daniel Brancamonte
Potosí, Potosí Department
Milenka Gamboa, MD, +59172416966, milicita@yahoo.com
- Recruiting
Hospital del Niño Sor Teresa Huarte Tama
Sucre, Chuquisaca Department
Jhovana Elizabeth Paco Barral, MD, +59165707332, jpacobarral@gmail.com
- Recruiting
Hospital Regional San Juan de Dios
Tarija, Tarija Department
Nils Casson, MD, +59176187393, nilsjefe1@hotmail.com
Peru2 sites, 2 recruiting
- Recruiting
Hospital Nacional Adolfo Guevara Velasco
Cusco
Yesica Luna, MD, +51992818282, yesilunde@hotmail.com
- Recruiting
Hospital de Emergencias Pediatricas
Lima, Lima Province
Yhuri Carreazo, MD, +51997252543, yhuroc@gmail.com
Uruguay2 sites, 2 recruiting
- Recruiting
Centro Hospitalario Pereira Rossell
Montevideo, Montevideo Department, 11600
SEBASTIAN GONZALEZ-DAMBRAUSKAS, MD, +5759899585225, sgdambrauskas@gmail.com
- Recruiting
Círculo Católico
Montevideo
Mónica Decia, MD, +59899664031, monicadecia@gmail.com
Chile1 site, 1 recruiting
- Recruiting
Clinica Indisa
Santiago
Victor Monreal, MD, +5693373202, victor.monreal@indisa.cl
About this study
Official 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.
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.
- Being tested
- Geographic Altitude
- Medical subject headings
- Respiratory Distress Syndrome, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geographic AltitudeOther
Also called Altitude Exposure
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Altitude PICUs | Children with PARDS admitted to pediatric intensive care units located at altitudes between 0-1500 meters above sea level. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Geographic Altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From PICU admission until hospital discharge (up to 90 days)
Secondary outcomes (3)
New morbidity at hospital discharge
Presence of new functional morbidity measured using Functional Status Score greater than 2.
Measured: From PICU admission until hospital discharge (up to 90 days)
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.
Measured: 28 days after initiation of invasive mechanical ventilation
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.
Measured: 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Pediatric Collaborative Network
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Colombia, Fundación Universitaria de Ciencias de la Salud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193771
- Sponsor's protocol ID
- LARED-001
- Acronym
- LARed-ALT
- Status last verified
- May 2026
- First submitted
- 18 Sep 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 40784821Pediatric 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 25647235Molano-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 39882326Jibaja 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07193771
- Acronym / sponsor ID
- LARed-ALT / LARED-001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Latin American Pediatric Collaborative NetworkUniversity, hospital or other
- Collaborators
- Universidad Nacional de Colombia, Fundación Universitaria de Ciencias de la Salud
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Altitude PICUs | – | Other: Geographic AltitudeChildren with PARDS admitted to pediatric intensive care units located at altitudes between 0-1500 meters above sea level. |
| Intermediate Altitude PICUs | – | Other: Geographic AltitudeChildren with PARDS admitted to pediatric intensive care units located at altitudes between 1501-2500 meters above sea level. |
| High Altitude PICUs | – | Other: Geographic AltitudeChildren with PARDS admitted to pediatric intensive care units located at altitudes between 2501-3500 meters above sea level. |
| Very High Altitude PICUs | – | Other: Geographic AltitudeChildren with PARDS admitted to pediatric intensive care units located at altitudes above 3500 meters above sea level. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geographic AltitudeAlso: Altitude ExposureParticipants 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 | High Altitude PICUs, Intermediate Altitude PICUs, Low Altitude PICUs, Very High Altitude PICUs |
Primary outcome
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.
3 secondary outcomes
New morbidity at hospital discharge
Time frame: From PICU admission until hospital discharge (up to 90 days)
Ventilator-free days at 28 days.
Time frame: 28 days after initiation of invasive mechanical ventilation
ICU-free days at 28 days.
Time frame: 28 days after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Results publication: PubMed 40784821Tinoco-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.
- Results publication: PubMed 25647235Pediatric 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.
- Results publication: PubMed 39882326Molano-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.
- Results publication: PubMed 31582181Jibaja 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Pediatric and Altitude Hypoxia, run by Latin American Pediatric Collaborative Network at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Colombia, Bolivia, Peru, Uruguay, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PABLO VASQUEZ-HOYOS, MD, MSc (573187172029, pablovasquezmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: From PICU admission until hospital discharge (up to 90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07193771, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.