Outcomes of Children After Hospitalization in Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neurocognitive tests.
- Who it may be relevant to
- Registry conditions: Renal Disease, Liver Diseases, Heart Diseases, Trauma Injury. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
After Pediatric Critical Illness (APCI)
Overview
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.
Interventions
- Other neurocognitive tests
Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.
Primary outcome measures
- Identify risk factors of PICS-p at 2 months post-PICU [Time frame: 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]
Secondary outcome measures (2)
- 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]
- Uncover additional post-PICU morbidities not detected within the framework of PICS-p. [Time frame: Until 36 months post PICU discharge]
Eligibility criteria
Inclusion criteria
- Children ≤18yo hospitalized in PICU for ≥96 hours
Exclusion criteria
- gestational age <37 weeks or age >18 years at PICU entry;
- admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
- anticipated life expectancy <1year (e.g., active do not resuscitate status).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 8 centers
- Alberta Children's Hospital — Calgary
- BC Children Hospital — Vancouver
- McMaster Children's Hospital — Hamilton
- Childrens Hospital of Eastern Ontario — Ottawa
- The Hospital for Sick Children — Toronto
- CHU Sainte-Justine — Montreal
- Montreal Children Hospital — Montreal
- Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke
Identifiers
NCT: NCT06124092 · CHUSJ MP-21-2023-5097