- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03585582
Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome (PARDS)
October 25, 2022 updated by: Sze Man Tse, St. Justine's Hospital
Pediatric Acute Respiratory Distress Syndrome: Determining Post-discharge Outcomes, the Effect of Early Diagnosis, and Identifying Inflammatory Signatures to Better Understand Disease Mechanism
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria.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.
Study Type
Observational
Enrollment (Anticipated)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sze Man Tse, MD
- Phone Number: 5409 514-345-4931
- Email: sze.man.tse@umontreal.ca
Study Contact Backup
- Name: Vincent Lague
- Phone Number: 514-345-4931
- Email: vincent.lague.hsj@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T 1C5
- Recruiting
- Sainte-Justine University Hospital Centre
-
Contact:
- Sze Man Tse, MD
- Phone Number: 5409 514-345-4931
- Email: sze.man.tse@umontreal.ca
-
Contact:
- Vincent Lague
- Phone Number: 514-345-4931
- Email: vincent.lague.hsj@ssss.gouv.qc.ca
-
Principal Investigator:
- Sze Man Tse, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the ICU at the CHUSJ, a pediatric tertiary care center
Description
Inclusion criteria:
- clinical diagnosis of PARDS, as defined by PALICC
- aged less than 18 years
- admitted to the intensive care unit
Exclusion Criteria
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PARDS survivors
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of respiratory symptoms
Time Frame: At 1 year following the discharge
|
Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)
|
At 1 year following the discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
non-respiratory PELOD-2 score
Time Frame: At 7 days
|
PELOD-2 score - validated score predictive of mortality (quantifies the severity of organ dysfunction).
There are 7 items describing 4 organ dysfunction (respiratory component is removed).
The score ranges from 0 to 25, with higher score indicating more organ dysfunction.
|
At 7 days
|
Pulmonary function - Forced expiratory volume in 1 second
Time Frame: At 1 year following the discharge
|
Forced expiratory volume in 1 second (FEV1) in L and z-score based on references from the Global Lung Initiative.
|
At 1 year following the discharge
|
Pulmonary function - Forced vital capacity (FVC)
Time Frame: At 1 year following the discharge
|
Forced vital capacity (FVC) in L and z-score based on references from the Global Lung Initiative.
|
At 1 year following the discharge
|
Pulmonary function - FEV1/FVC
Time Frame: At 1 year following the discharge
|
FEV1/FVC ratio z-score based on references from the Global Lung Initiative
|
At 1 year following the discharge
|
Pulmonary function - lung volumes
Time Frame: At 1 year following the discharge
|
Lung volumes (total lung capacity, functional residual capacity, residual volumes) in L. Outcome measured in patients 8 years and above only.
|
At 1 year following the discharge
|
Pulmonary function - diffusion capacity
Time Frame: At 1 year following the discharge
|
Diffusion capacity of CO (DLCO).
Outcome measured in patients 8 years and above only.
|
At 1 year following the discharge
|
Pulmonary function - maximal inspiratory and expiratory pressures
Time Frame: At 1 year following the discharge
|
Maximal inspiratory and expiratory pressures in cm H2O.
Outcome measured in patients 6 years and above only.
|
At 1 year following the discharge
|
Pulmonary function - resistance at 5Hz
Time Frame: At 1 year following the discharge
|
Respiratory resistance measured using oscillometry at 5 Hz.
Outcome measured in patients 3-5 years old and those who cannot perform spirometry.
|
At 1 year following the discharge
|
Cardiopulmonary exercise testing - VO2max
Time Frame: At 1 year following the discharge
|
VO2max measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
|
At 1 year following the discharge
|
Cardiopulmonary exercise testing - CO2 output
Time Frame: At 1 year following the discharge
|
CO2 output measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
|
At 1 year following the discharge
|
Cardiopulmonary exercise testing - respiratory exchange ratio
Time Frame: At 1 year following the discharge
|
Respiratory exchange ratio measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
|
At 1 year following the discharge
|
Cardiopulmonary exercise testing - anaerobic threshold
Time Frame: At 1 year following the discharge
|
Anaerobic threshold measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
|
At 1 year following the discharge
|
Health-related quality of life - Infant Toddler Quality of Life Questionnaire
Time Frame: At 1 year following the discharge
|
Health-related quality of life using the Infant Toddler Quality of Life Questionnaire (ages 2 months to 2 years).
There are 8 scales to this 47-item questionnaire: overall health, physical abilities, growth and development, bodily pain/discomfort, temperament and mood, combined behavior, general health perceptions, change in health.
There are also 3 scales that assess the impact on the parent: parental impact-emotional, parental impact-time, family cohesion.
Transformed scores for all scales range from 0 to 100, with a higher score indicating better health.
|
At 1 year following the discharge
|
Health-related quality of life - Pediatric Quality of Life Inventory
Time Frame: At 1 year following the discharge
|
Health-related quality of life using the Pediatric Quality of Life Inventory (≥2 years), Generic core scale.
There are separate versions for 2-4 year-olds (parent report only), 5-7 (parent and child report), 8-12 (parent and child report), 13-18 (parent and child report).
Scores are transformed on a scale from 0 to 100, with a higher score indicating better health-related quality of life.
|
At 1 year following the discharge
|
Mental health - Child Behavior Checklist
Time Frame: At 1 year following the discharge
|
Mental health assessed by the parent-completed Child Behavior Checklist (age ≥ 18 months).
The 6 scales are based on the DSM5: depressive problems, anxiety problems, somatic problems, attention deficit/hyperactivity problems, oppositional defiant problems, conduct problems.
The raw scores are transformed into percentiles for each scale.
The higher the percentile, the more problems there are.
|
At 1 year following the discharge
|
Post-traumatic stress syndrome - Children's Impact of Event Scales
Time Frame: At 1 year following the discharge
|
Post-traumatic stress syndrome symptoms using the Children's Impact of Event Scales (≥ 7 years).
There are 8 items that are scored on a four point scale (total score from 0 to 40).
A total score of 17 or more indicates symptoms suggestive of PTSD.
|
At 1 year following the discharge
|
Post-traumatic stress syndrome - parents PTSD Checklist
Time Frame: At 1 year following the discharge
|
Post-traumatic stress syndrome symptoms in the parents using the parents PTSD Checklist.
There are 20 items that are scored from 0-4 each (total score from 0 to 80).
A PCL-5 score of 33 or more indicates symptoms suggestive of PTSD.
|
At 1 year following the discharge
|
Health resources use
Time Frame: At 1 year following the discharge
|
Health resources use, including all-cause emergency department visits or re-hospitalizations.
|
At 1 year following the discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sze Man Tse, MD, St. Justine's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2018
Primary Completion (Anticipated)
February 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
May 10, 2018
First Submitted That Met QC Criteria
June 29, 2018
First Posted (Actual)
July 13, 2018
Study Record Updates
Last Update Posted (Actual)
October 27, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRC-155352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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