Outcomes of Children After Hospitalization in Intensive Care Unit (APCI)

November 3, 2023 updated by: Genevieve Du Pont-Thibodeau, St. Justine's Hospital

After Pediatric Critical Illness (APCI)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

690

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • British Colombia
      • Vancouver, British Colombia, Canada, V6H 3N1
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Ottawa, Ontario, Canada, K1H 8L1
      • Toronto, Ontario, Canada, M5G 1X8
    • Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify risk factors of PICS-p at 2 months post-PICU
Time Frame: 2 months after PICU discharge
Identification of modifiable and non-modifiable risk factors
2 months after PICU discharge
Develop and validate a model predictive of PICS-p 2 months post PICU
Time Frame: 2 months after PICU discharge
The model will allow detection at PICU discharge of children in need of post-PICU follow-up
2 months after PICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU
Time Frame: At 2 months, 12, 18 months and 36 months post PICU discharge
Identify which domain gets impacted and when during the course of the follow-up
At 2 months, 12, 18 months and 36 months post PICU discharge
Uncover additional post-PICU morbidities not detected within the framework of PICS-p.
Time Frame: Until 36 months post PICU discharge
Detection of morbidities through the medical provider interview that are not included in the current framework.
Until 36 months post PICU discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe families' healthcare requirements throughout their recovery process after PICU.
Time Frame: Until 36 months post PICU discharge
Descrie the variety of healthcare professional and medical required post PICU hospitalization.
Until 36 months post PICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Geneviève Du Pont-Thibodeau, MD, St. Justine's Hospital
  • Principal Investigator: Laurence Cucharme-Crevier, MD, St. Justine's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUSJ MP-21-2023-5097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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