Clinical trial Recruiting at 18 sites Observational Ages 1 Month to 18

How altitude affects outcomes for children with acute respiratory distress

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.

Run by Latin American Pediatric Collaborative Network · NCT07193771 · Data updated 2026-11-12

This project will see if higher altitude and differences in hospital critical-care resources change outcomes for children (1 month–18 years) with PARDS who need invasive mechanical ventilation.

More Acute Respiratory Distress Syndrome trials

Quick facts

Study typeObservational
Ages1 Month to 18 Years
SexAll
Enrollment1600 (estimated)
SponsorLatin American Pediatric Collaborative Network
Academic / other
Locations20 sites (Sucre, Chuquisaca Department and 19 other locations)
StatusRecruiting
StartedNovember 1, 2025
Main results expectedNovember 2027
Study endsMarch 2028
Registry record updatedJune 2, 2026
Trial IDNCT07193771 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 1 month (corrected gestational age) to 18 years admitted to a PICU who require invasive mechanical ventilation and meet PALICC criteria for PARDS are the intended participants.

Probably not a fit

Children with active perinatal lung disease, those who received ECMO before or within 24 hours of PARDS diagnosis, patients with pre-established palliative or limitation-of-therapy orders, and PICU readmissions are excluded and unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study will collect prospective and retrospective clinical, physiological, and institutional data from PICUs located at different geographic altitudes. Investigators will record patient demographics, oxygenation and ventilation metrics, and details about available equipment and trained staff at each site. Analyses will examine how altitude and resource availability interact with oxygenation/ventilation parameters to influence outcomes such as mortality, duration of mechanical ventilation, and complications. The goal is to identify management gaps and produce context-specific recommendations to improve PARDS care across varied resource settings.

Why it matters

Potential benefit: If successful, the findings could inform altitude- and resource-adapted guidelines that improve care and reduce outcome disparities for children with PARDS.

How similar studies have gone: Smaller adult and pediatric reports have suggested altitude and resource differences can affect hypoxemia and outcomes, but large multicenter pediatric data are limited, making this approach relatively novel for PARDS.

Who can join: the full rules

Show full inclusion / exclusion criteria
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:

* 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).

Where it's running

  • 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, Colombia
    Recruiting
Show 14 more locations
  • Sociedad de Cirugia de Bogota Hospital de San Jose
    Bogotá, Dc, Colombia
    Recruiting
  • Fundación HOMI
    Bogotá, Dc, 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, Colombia
    Recruiting
  • Clínica UROS S.A
    Neiva, Huila Department, Colombia
    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, Uruguay
    Recruiting
  • Círculo Católico
    Montevideo, Uruguay
    Recruiting
  • Fundación Valle de Lili
    Cali, Valle del Cauca Department, Colombia
    Not yet recruiting
  • LaCardio
    Bogotá, Colombia
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.