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Outcomes of Children After Hospitalization in Intensive Care Unit

After Pediatric Critical Illness (APCI)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06124092
Acronym
APCI
Enrollment
690
Registered
2023-11-09
Start date
2024-03-31
Completion date
2029-03-31
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pediatric Intensive Care Unit, PICU

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.

Interventions

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

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
St. Justine's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Identify risk factors of PICS-p at 2 months post-PICU2 months after PICU dischargeIdentification of modifiable and non-modifiable risk factors
Develop and validate a model predictive of PICS-p 2 months post PICU2 months after PICU dischargeThe model will allow detection at PICU discharge of children in need of post-PICU follow-up

Secondary

MeasureTime frameDescription
Describe the incidence of each of the five domains of PICS-p across the first two years post-PICUAt 2 months, 12, 18 months and 36 months post PICU dischargeIdentify 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 dischargeDetection of morbidities through the medical provider interview that are not included in the current framework.

Other

MeasureTime frameDescription
Describe families' healthcare requirements throughout their recovery process after PICU.Until 36 months post PICU dischargeDescrie the variety of healthcare professional and medical required post PICU hospitalization.

Countries

Canada

Contacts

Primary ContactGeneviève Du Pont-Tibodeau, MD
genevieve.du.pont-thibodeau.med@ssss.gouv.qc.ca514-345-4931
Backup ContactLaurence Ducharme-Crevier, MD
laurence.ducharme.crevier.med@ssss.gouv.qc.ca514-345-4931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026