Altitude and Outcomes in Pediatric ARDS: A Multicenter Study
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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Geographic Altitude
Other interventionParticipants 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.
Treatment groups
1,600 Participants
are divided into 4 treatment groupsGroup A: Low Altitude PICUs1 intervention
Group B: Intermediate Altitude PICUs1 intervention
Group C: High Altitude PICUs1 intervention
Group D: Very High Altitude PICUs1 intervention
Trial outcomes
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.
Time frame
From PICU admission until hospital discharge (up to 90 days)Secondary outcomes
1
New morbidity at hospital discharge
Presence of new functional morbidity measured using Functional Status Score greater than 2.
Time frame
From PICU admission until hospital discharge (up to 90 days)2
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.
Time frame
28 days after initiation of invasive mechanical ventilation3
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.
Time frame
28 days after ICU admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Latin American Pediatric Collaborative Network
Lead sponsor
Universidad Nacional de Colombia
Collaborator
Fundación Universitaria de Ciencias de la Salud
Collaborator
Source ClinicalTrials.gov