Clinical trial NCT06124092: Outcomes of Children After Hospitalization in Intensive Care Unit
Official title: After Pediatric Critical Illness (APCI)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Renal Disease
Liver Diseases
Heart Diseases
Trauma Injury
Sepsis
Septic Shock
Pneumonia
Bronchiolitis
Keywords: Pediatric Intensive Care Unit
PICU
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-11-09
Enrollment: 690
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient admitted to Pediatric Intensive Care Unit for 96 hours or more will be included in the study unless they age a gestionnal age \<37 weeks or are over 18 years-old or were admitted to PICu for congenital heart surgery (as they are followed in neuro-cardiac clinic) and for whom the life expectancy is less than 1 year.

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.

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).

Primary outcomes:
measure: Identify risk factors of PICS-p at 2 months post-PICU
timeFrame: 2 months after PICU discharge
measure: Develop and validate a model predictive of PICS-p 2 months post PICU
timeFrame: 2 months after PICU discharge
Secondary outcomes:
measure: Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU
timeFrame: At 2 months, 12, 18 months and 36 months post PICU discharge
measure: Uncover additional post-PICU morbidities not detected within the framework of PICS-p.
timeFrame: Until 36 months post PICU discharge
Other outcomes:
measure: Describe families' healthcare requirements throughout their recovery process after PICU.
timeFrame: Until 36 months post PICU discharge
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children Hospital
state: British Colombia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Childrens Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Geneviève Du Pont-Thibodeau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Justine's Hospital
name: Laurence Cucharme-Crevier, MD
role: PRINCIPAL_INVESTIGATOR
References: