APCI: Outcomes of Children After Hospitalization in Intensive Care Unit

Sponsor
St. Justine's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06124092
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
690
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60
86.3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: neurocognitive tests

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 Design

Study Type:
Observational
Anticipated Enrollment :
690 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
After Pediatric Critical Illness (APCI)
Anticipated Study Start Date :
Mar 1, 2024
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Mar 1, 2029

Outcome Measures

Primary Outcome Measures

  1. Identify risk factors of PICS-p at 2 months post-PICU [2 months after PICU discharge]

    Identification of modifiable and non-modifiable risk factors

  2. Develop and validate a model predictive of PICS-p 2 months post PICU [2 months after PICU discharge]

    The model will allow detection at PICU discharge of children in need of post-PICU follow-up

Secondary Outcome Measures

  1. Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU [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

  2. Uncover additional post-PICU morbidities not detected within the framework of PICS-p. [Until 36 months post PICU discharge]

    Detection of morbidities through the medical provider interview that are not included in the current framework.

Other Outcome Measures

  1. Describe families' healthcare requirements throughout their recovery process after PICU. [Until 36 months post PICU discharge]

    Descrie the variety of healthcare professional and medical required post PICU hospitalization.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
2 BC Children Hospital Vancouver British Colombia Canada V6H 3N1
3 McMaster Children's Hospital Hamilton Ontario Canada L8N 3Z5
4 Childrens Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
5 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
6 CHU Sainte-Justine Montréal Quebec Canada H3T 1C5
7 Montreal Children Hospital Montréal Quebec Canada H4A 3J1
8 Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec Canada J1J 3H5

Sponsors and Collaborators

  • St. Justine's Hospital
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genevieve Du Pont-Thibodeau, MD, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT06124092
Other Study ID Numbers:
  • CHUSJ MP-21-2023-5097
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Genevieve Du Pont-Thibodeau, MD, St. Justine's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2023