Pediatric Acute Respiratory Distress SyndromePARDSNCT03585582
Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome
An observational study of Pediatric Acute Respiratory Distress Syndrome, run by St. Justine's Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome
- What is being tested?
- Prospective follow-up
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2018to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients admitted to the ICU at the CHUSJ, a pediatric tertiary care center
Who may be able to join
- clinical diagnosis of PARDS, as defined by PALICC
- aged less than 18 years
- admitted to the intensive care unit
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sainte-Justine University Hospital Centre
Montreal, Quebec, H3T 1C5
Sze Man Tse, MD, 514-345-4931 ext. 5409, sze.man.tse@umontreal.ca
Vincent Lague, 514-345-4931, vincent.lague.hsj@ssss.gouv.qc.ca
About this study
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
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.
Read the 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.
- Being tested
- Prospective follow-up
- Keywords
- Respiratory Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective follow-upOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Prospective follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of respiratory symptoms
Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)
Measured: At 1 year following the discharge
Secondary outcomes (18)
non-respiratory PELOD-2 score
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.
Measured: At 7 days
Pulmonary function - Forced expiratory volume in 1 second
Forced expiratory volume in 1 second (FEV1) in L and z-score based on references from the Global Lung Initiative.
Measured: At 1 year following the discharge
Pulmonary function - Forced vital capacity (FVC)
Forced vital capacity (FVC) in L and z-score based on references from the Global Lung Initiative.
Measured: At 1 year following the discharge
Pulmonary function - FEV1/FVC
FEV1/FVC ratio z-score based on references from the Global Lung Initiative
Measured: At 1 year following the discharge
Pulmonary function - lung volumes
Lung volumes (total lung capacity, functional residual capacity, residual volumes) in L. Outcome measured in patients 8 years and above only.
Measured: At 1 year following the discharge
Pulmonary function - diffusion capacity
Diffusion capacity of CO (DLCO). Outcome measured in patients 8 years and above only.
Measured: At 1 year following the discharge
Pulmonary function - maximal inspiratory and expiratory pressures
Maximal inspiratory and expiratory pressures in cm H2O. Outcome measured in patients 6 years and above only.
Measured: At 1 year following the discharge
Pulmonary function - resistance at 5Hz
Respiratory resistance measured using oscillometry at 5 Hz. Outcome measured in patients 3-5 years old and those who cannot perform spirometry.
Measured: At 1 year following the discharge
Cardiopulmonary exercise testing - VO2max
VO2max measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Measured: At 1 year following the discharge
Cardiopulmonary exercise testing - CO2 output
CO2 output measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Measured: At 1 year following the discharge
Cardiopulmonary exercise testing - respiratory exchange ratio
Respiratory exchange ratio measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Measured: At 1 year following the discharge
Cardiopulmonary exercise testing - anaerobic threshold
Anaerobic threshold measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Measured: At 1 year following the discharge
Health-related quality of life - Infant Toddler Quality of Life Questionnaire
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.
Measured: At 1 year following the discharge
Health-related quality of life - Pediatric Quality of Life Inventory
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.
Measured: At 1 year following the discharge
Mental health - Child Behavior Checklist
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.
Measured: At 1 year following the discharge
Post-traumatic stress syndrome - Children's Impact of Event Scales
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.
Measured: At 1 year following the discharge
Post-traumatic stress syndrome - parents PTSD Checklist
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.
Measured: At 1 year following the discharge
Health resources use
Health resources use, including all-cause emergency department visits or re-hospitalizations.
Measured: At 1 year following the discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start31 Oct 2018
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Sze Man Tse, St. Justine's Hospital
- Investigators
- Sze Man Tse, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585582
- Sponsor's protocol ID
- MRC-155352
- Acronym
- PARDS
- Status last verified
- Oct 2022
- First submitted
- 10 May 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03585582
- Acronym / sponsor ID
- PARDS / MRC-155352
- Keywords
- Respiratory Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PARDS survivors | – | Other: Prospective follow-up1. Children <18 years 2. diagnosed with PARDS, as defined by PALICC 3. admitted to the ICU at the CHUSJ, a pediatric tertiary care center |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients admitted to the ICU at the CHUSJ, a pediatric tertiary care center
Key inclusion criteria (3 listed)
- clinical diagnosis of PARDS, as defined by PALICC
- aged less than 18 years
- admitted to the intensive care unit
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective follow-upThis is a prospective follow-up study to assess of outcomes at 1 year following the discharge from the hospitalization during which PARDS was diagnosed | Other | PARDS survivors |
Primary outcome
Prevalence of respiratory symptoms
Time frame: At 1 year following the discharge
Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)
18 secondary outcomes
non-respiratory PELOD-2 score
Time frame: At 7 days
Pulmonary function - Forced expiratory volume in 1 second
Time frame: At 1 year following the discharge
Pulmonary function - Forced vital capacity (FVC)
Time frame: At 1 year following the discharge
Pulmonary function - FEV1/FVC
Time frame: At 1 year following the discharge
Pulmonary function - lung volumes
Time frame: At 1 year following the discharge
Pulmonary function - diffusion capacity
Time frame: At 1 year following the discharge
Pulmonary function - maximal inspiratory and expiratory pressures
Time frame: At 1 year following the discharge
Pulmonary function - resistance at 5Hz
Time frame: At 1 year following the discharge
Cardiopulmonary exercise testing - VO2max
Time frame: At 1 year following the discharge
Cardiopulmonary exercise testing - CO2 output
Time frame: At 1 year following the discharge
Cardiopulmonary exercise testing - respiratory exchange ratio
Time frame: At 1 year following the discharge
Cardiopulmonary exercise testing - anaerobic threshold
Time frame: 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 - Pediatric Quality of Life Inventory
Time frame: At 1 year following the discharge
Mental health - Child Behavior Checklist
Time frame: 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 - parents PTSD Checklist
Time frame: At 1 year following the discharge
Health resources use
Time frame: At 1 year following the discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sze Man Tse, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Acute Respiratory Distress Syndrome, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sze Man Tse, MD (514-345-4931 ext. 5409, sze.man.tse@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of respiratory symptoms (time frame: At 1 year following the discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.