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NCT Number: NCT06124092

Outcomes of Children After Hospitalization in Intensive Care Unit

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.

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Key information

Conditions

Renal Disease Accidental Injuries Bronchial Diseases Bronchiolitis Bronchitis Cardiovascular Diseases Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Infections Inflammation Kidney Diseases Liver Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome Trauma Injury Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neurocognitive tests

Other

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

Other names: Quality of life

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. 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

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Geneviève Du Pont-Tibodeau, MD

CONTACT

[email protected]

514-345-4931 ext. 5553

Laurence Ducharme-Crevier, MD

CONTACT

[email protected]

514-345-4931 ext. 4118

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

After Pediatric Critical Illness (APCI)

Acronym: APCI

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Nov 9, 2023
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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