Outcomes of Children After Hospitalization in Intensive Care Unit

Not yet recruiting

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

• Registration Number: NCT06124092
• Lead Sponsor: St. Justine's Hospital

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Study Start: 2024-03
• Primary Completion: 2027-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 690

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Identify risk factors of PICS-p at 2 months post-PICU	2 months after PICU discharge	Identification of modifiable and non-modifiable risk factors

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (8)

Montreal Children Hospital; 🇨🇦 Montréal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada

BC Children Hospital; 🇨🇦 Vancouver, British Colombia, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Childrens Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada