Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome

Pediatric Acute Respiratory Distress Syndrome Clinical Trial

— PARDS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03585582
• Other study ID #: MRC-155352
• Status: Recruiting
• Start date: October 31, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2022
• Source: St. Justine's Hospital
• Contact: Sze Man Tse, MD
• Phone: 514-345-4931
• Email: sze.man.tse[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 improve the care of these children.

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 Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: August 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion criteria:

• clinical diagnosis of PARDS, as defined by PALICC

• aged less than 18 years

• admitted to the intensive care unit

Exclusion Criteria

• none

Related Conditions & MeSH terms

• Acute Lung Injury
• Pediatric Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Canada	Sainte-Justine University Hospital Centre	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of respiratory symptoms	Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)	At 1 year following the discharge
Secondary	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.	At 7 days
Secondary	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.	At 1 year following the discharge
Secondary	Pulmonary function - Forced vital capacity (FVC)	Forced vital capacity (FVC) in L and z-score based on references from the Global Lung Initiative.	At 1 year following the discharge
Secondary	Pulmonary function - FEV1/FVC	FEV1/FVC ratio z-score based on references from the Global Lung Initiative	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	Pulmonary function - diffusion capacity	Diffusion capacity of CO (DLCO). Outcome measured in patients 8 years and above only.	At 1 year following the discharge
Secondary	Pulmonary function - maximal inspiratory and expiratory pressures	Maximal inspiratory and expiratory pressures in cm H2O. Outcome measured in patients 6 years and above only.	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	Cardiopulmonary exercise testing - VO2max	VO2max measured using a standardized maximal incremental cycle ergometry protocol in children = 8 years.	At 1 year following the discharge
Secondary	Cardiopulmonary exercise testing - CO2 output	CO2 output measured using a standardized maximal incremental cycle ergometry protocol in children = 8 years.	At 1 year following the discharge
Secondary	Cardiopulmonary exercise testing - respiratory exchange ratio	Respiratory exchange ratio measured using a standardized maximal incremental cycle ergometry protocol in children = 8 years.	At 1 year following the discharge
Secondary	Cardiopulmonary exercise testing - anaerobic threshold	Anaerobic threshold measured using a standardized maximal incremental cycle ergometry protocol in children = 8 years.	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	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.	At 1 year following the discharge
Secondary	Health resources use	Health resources use, including all-cause emergency department visits or re-hospitalizations.	At 1 year following the discharge