Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome
PARDS
Pediatric Acute Respiratory Distress Syndrome: Determining Post-discharge Outcomes, the Effect of Early Diagnosis, and Identifying Inflammatory Signatures to Better Understand Disease Mechanism
1 other identifier
observational
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 13, 2018
CompletedStudy Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedOctober 27, 2022
October 1, 2022
4.3 years
May 10, 2018
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of respiratory symptoms
Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)
At 1 year following the discharge
Secondary Outcomes (18)
non-respiratory PELOD-2 score
At 7 days
Pulmonary function - Forced expiratory volume in 1 second
At 1 year following the discharge
Pulmonary function - Forced vital capacity (FVC)
At 1 year following the discharge
Pulmonary function - FEV1/FVC
At 1 year following the discharge
Pulmonary function - lung volumes
At 1 year following the discharge
- +13 more secondary outcomes
Study Arms (1)
PARDS survivors
1. Children \<18 years 2. diagnosed with PARDS, as defined by PALICC 3. admitted to the ICU at the CHUSJ, a pediatric tertiary care center
Interventions
This is a prospective follow-up study to assess of outcomes at 1 year following the discharge from the hospitalization during which PARDS was diagnosed
Eligibility Criteria
Patients admitted to the ICU at the CHUSJ, a pediatric tertiary care center
You may qualify if:
- clinical diagnosis of PARDS, as defined by PALICC
- aged less than 18 years
- admitted to the intensive care unit
You may not qualify if:
- \- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sainte-Justine University Hospital Centre
Montreal, Quebec, H3T 1C5, Canada
Biospecimen
blood, urine, and tracheal or nasopharyngeal aspirate samples
Study Officials
- PRINCIPAL INVESTIGATOR
Sze Man Tse, MD
St. Justine's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Respirologist, Assistant Clinical Professor
Study Record Dates
First Submitted
May 10, 2018
First Posted
July 13, 2018
Study Start
October 31, 2018
Primary Completion
February 1, 2023
Study Completion
August 1, 2023
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share