Outcomes of Children After Hospitalization in Intensive Care Unit

NCT ID: NCT06124092

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 690 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2029-03-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

neurocognitive tests

Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.

Intervention Type: OTHER

Other Intervention Names

Quality of life

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).

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Genevieve Du Pont-Thibodeau

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geneviève Du Pont-Thibodeau, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Laurence Cucharme-Crevier, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

BC Children Hospital

Vancouver, British Colombia, Canada

McMaster Children's Hospital

Hamilton, Ontario, Canada

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Montreal Children Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Central Contacts

Geneviève Du Pont-Tibodeau, MD

Role: CONTACT

genevieve.du.pont-thibodeau.med@ssss.gouv.qc.ca

514-345-4931 ext. 5553

Laurence Ducharme-Crevier, MD

Role: CONTACT

laurence.ducharme.crevier.med@ssss.gouv.qc.ca

514-345-4931 ext. 4118

Facility Contacts

Laurie Lee, MD

Role: primary

Laurie.Lee@albertahealthservices.ca

Jenny Retallack, MD

Role: primary

jretallack@cw.bc.ca

Karen Choong, MD

Role: primary

choongk@mcmaster.ca

Dayre McNally, MD

Role: primary

dmcnally@cheo.on.ca

Nicole McKinnon

Role: primary

nicole.mckinnon@sickkids.ca

Nadia Roumeliotis, MD

Role: primary

nadezhda.roumeliotis.med@ssss.gouv.qc.ca

514-345-4931 ext. 7177

Patricia Fontela, MD

Role: primary

patricia.fontela@mcgill.ca

Jean-Sébastien Tremblay-Roy, MD

Role: primary

jean-sebastien.tremblay-roy@usherbrooke.ca

819-346-1100 ext. 70188

Other Identifiers

CHUSJ MP-21-2023-5097

Identifier Type: -

Identifier Source: org_study_id