Health Trials

Altitude and Outcomes in Pediatric ARDS: A Multicenter Study

ConditionsRespiratory Distress Syndrome, PediatricAltitude HypoxiaHigh Altitude Effects
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorLatin American Pediatric Collaborative Network

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • Geographic Altitude

Treatment groups

1,600 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Latin American Pediatric Collaborative Network

Lead sponsor

Universidad Nacional de Colombia

Collaborator

Fundación Universitaria de Ciencias de la Salud

Collaborator

Source ClinicalTrials.gov