Clinical trial NCT03585582: Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome
Official title: Pediatric Acute Respiratory Distress Syndrome: Determining Post-discharge Outcomes, the Effect of Early Diagnosis, and Identifying Inflammatory Signatures to Better Understand Disease Mechanism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Acute Respiratory Distress Syndrome
Keywords: Respiratory Health
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-07-13
Enrollment: 77
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU at the CHUSJ, a pediatric tertiary care center

Brief summary: In this study, the investigators aim to better characterize the outcomes of pediatric acute respiratory distress syndrome (PARDS) survivors, to examine whether subgroups of children with PARDS can be identified, and to determine whether an earlier diagnosis of PARDS using a computerized decision support system will improve the care of these children.

Detailed description: Pediatric acute respiratory distress syndrome (PARDS), a heterogeneous clinical syndrome characterized by acute lung injury and hypoxemia, affects up to 10% of pediatric intensive care unit (ICU) patients and has a mortality rate of 18-27%. Because children who survived PARDS are still developing, long-term morbidities are highly relevant, although data on the outcomes of PARDS survivors is lacking. Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria. Some studies focused on pulmonary function but not on other patient-oriented outcomes such as respiratory symptoms, mental health issues, quality of life, and health care resource use, all of which have been identified as prevalent issues in adult ARDS survivors. Recently, adult studies have identified 2 distinct ARDS subphenotypes with differential responses to treatment using clinical and limited biological data, providing insight on the pathophysiology of ARDS. Whether these phenotypes are present in PARDS is unknown. Furthermore, integrating newer technologies such as transcriptomics in the identification of subphenotypes may improve our understanding of disease mechanisms. Finally, delays in ARDS diagnosis are common and compliance with current ARDS ventilation management guidelines is poor, ranging from 20-39% even in patients selected for clinical trials. Thus, novel methods such as decision support systems may play a role in the diagnosis and management of PARDS patients, although this remains to be evaluated.

Eligibility criteria: Inclusion criteria:

* clinical diagnosis of PARDS, as defined by PALICC
* aged less than 18 years
* admitted to the intensive care unit

Exclusion Criteria

- none

Primary outcomes:
measure: Prevalence of respiratory symptoms
timeFrame: At 1 year following the discharge
Secondary outcomes:
measure: non-respiratory PELOD-2 score
timeFrame: At 7 days
measure: Pulmonary function - Forced expiratory volume in 1 second
timeFrame: At 1 year following the discharge
measure: Pulmonary function - Forced vital capacity (FVC)
timeFrame: At 1 year following the discharge
measure: Pulmonary function - FEV1/FVC
timeFrame: At 1 year following the discharge
measure: Pulmonary function - lung volumes
timeFrame: At 1 year following the discharge
measure: Pulmonary function - diffusion capacity
timeFrame: At 1 year following the discharge
measure: Pulmonary function - maximal inspiratory and expiratory pressures
timeFrame: At 1 year following the discharge
measure: Pulmonary function - resistance at 5Hz
timeFrame: At 1 year following the discharge
measure: Cardiopulmonary exercise testing - VO2max
timeFrame: At 1 year following the discharge
measure: Cardiopulmonary exercise testing - CO2 output
timeFrame: At 1 year following the discharge
measure: Cardiopulmonary exercise testing - respiratory exchange ratio
timeFrame: At 1 year following the discharge
measure: Cardiopulmonary exercise testing - anaerobic threshold
timeFrame: At 1 year following the discharge
measure: Health-related quality of life - Infant Toddler Quality of Life Questionnaire
timeFrame: At 1 year following the discharge
measure: Health-related quality of life - Pediatric Quality of Life Inventory
timeFrame: At 1 year following the discharge
measure: Mental health - Child Behavior Checklist
timeFrame: At 1 year following the discharge
measure: Post-traumatic stress syndrome - Children's Impact of Event Scales
timeFrame: At 1 year following the discharge
measure: Post-traumatic stress syndrome - parents PTSD Checklist
timeFrame: At 1 year following the discharge
measure: Health resources use
timeFrame: At 1 year following the discharge
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Sainte-Justine University Hospital Centre
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Sze Man Tse, MD
role: PRINCIPAL_INVESTIGATOR
References: