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Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome (PARDS)

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ClinicalTrials.gov Identifier: NCT03585582
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Sze Man Tse, St. Justine's Hospital

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.

Condition or disease Intervention/treatment
Pediatric Acute Respiratory Distress Syndrome Other: Prospective follow-up

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 Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria.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.

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Study Type : Observational
Estimated Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : October 31, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 1, 2021


Group/Cohort Intervention/treatment
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
Other: Prospective follow-up
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




Primary Outcome Measures :
  1. Prevalence of respiratory symptoms [ Time Frame: At 1 year following the discharge ]
    Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Health resources use [ Time Frame: At 1 year following the discharge ]
    Health resources use, including all-cause emergency department visits or re-hospitalizations.


Biospecimen Retention:   Samples Without DNA
blood, urine, and tracheal or nasopharyngeal aspirate samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ICU at the CHUSJ, a pediatric tertiary care center
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585582


Contacts
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Contact: Sze Man Tse, MD 514-345-4931 ext 5409 sze.man.tse@umontreal.ca
Contact: Ilona Shemyakina, BSc 514-345-4931 ext 4053 ilona.shemyakina@recherche-ste-justine.qc.ca

Locations
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Canada, Quebec
Sainte-Justine University Hospital Centre Not yet recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Sze Man Tse, MD    514-345-4931 ext 5409    sze.man.tse@umontreal.ca   
Contact: Ilona Shemyakina, BSc    514-345-4931 ext 4053    ilona.shemyakina@recherche-ste-justine.qc.ca   
Principal Investigator: Sze Man Tse, MD         
Sponsors and Collaborators
St. Justine's Hospital
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Sze Man Tse, MD St. Justine's Hospital

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Responsible Party: Sze Man Tse, Pediatric Respirologist, Assistant Clinical Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03585582     History of Changes
Other Study ID Numbers: MRC-155352
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sze Man Tse, St. Justine's Hospital:
Respiratory Health

Additional relevant MeSH terms:
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Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury