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ClinicalTrials.gov ID

NCT06124092

Lead Sponsor

St. Justine's HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

690Estimated

Last Update Posted

Nov 9, 2023Actual

Start Date

Mar 2024Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 2029Estimated

Official Title

After Pediatric Critical Illness (APCI)

Brief Summary

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p).

It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

Detailed Description

The Pediatric Post-Intensive Care Syndrome (PICS-p) is a newly developed conceptual framework that incorporates the constellation of morbidities that are increasingly recognized to affect children and their families after a critical illness. Experts define PICS-p as a new or worsening impairment in any of the following 5 domains of child health: physical, cognitive, emotional, social, or family.

In contrast to well established follow-up programs in adults, there is currently a lack of systematic follow-up of PICU survivors which prevents both the recognition and management of PICS-p. The absence of granular, empirical data on the recovery of PICU children impedes both the identification and management of PICS-p.

This project is a prospective Canadian multicenter cohort study to identify risk factors of PICS-p, develop and validate a predictive model for PICS-p to detect at-risk children, characterize each domain of PICS-p over two years post critical illness and uncover additional morbidities that are not captured using the current PICS-p framework. This study will provide granular, empirical data on which to build developmentally appropriate and tailored screening, management, and intervention programs during and after PICU to improve the global recovery of critically ill children and their family.

• Renal Disease
• Liver Diseases
• Heart Diseases
• Trauma Injury
• Sepsis
• Septic Shock
• Pneumonia
• Bronchiolitis

• neurocognitive tests

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Children ≤18yo hospitalized in PICU for ≥96 hours

Exclusion Criteria:

1. gestational age <37 weeks or age >18 years at PICU entry;
2. admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
3. anticipated life expectancy <1year (e.g., active do not resuscitate status).

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

St. Justine's HospitalOTHER

Collaborators

Canadian Institutes of Health Research (CIHR)OTHER_GOV

nadezhda.roumeliotis.med@ssss.gouv.qc.ca514-345-4931 ext. 7177

patricia.fontela@mcgill.ca