An observational study in Renal Disease, Liver Diseases and Heart Diseases, sponsored by St. Justine's Hospital. Not yet recruiting at 8 sites in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by St. Justine's Hospital · Observational
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.
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.
969 studies on the registry are indexed under Kidney Diseases; 183 are open to participants now.
This study's planned enrollment of 690 is above the median of 245 across 277 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient admitted to Pediatric Intensive Care Unit for 96 hours or more will be included in the study unless they age a gestionnal age \<37 weeks or are over 18 years-old or were admitted to PICu for congenital heart surgery (as they are followed in neuro-cardiac clinic) and for whom the life expectancy is less than 1 year.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.
Also known as: Quality of life
Identify risk factors of PICS-p at 2 months post-PICU
Identification of modifiable and non-modifiable risk factors
Time frame: 2 months after PICU discharge
Develop and validate a model predictive of PICS-p 2 months post PICU
The model will allow detection at PICU discharge of children in need of post-PICU follow-up
Time frame: 2 months after PICU discharge
Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU
Identify which domain gets impacted and when during the course of the follow-up
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.
Detection of morbidities through the medical provider interview that are not included in the current framework.
Time frame: Until 36 months post PICU discharge
Describe families' healthcare requirements throughout their recovery process after PICU.
Descrie the variety of healthcare professional and medical required post PICU hospitalization.
Time frame: Until 36 months post PICU discharge
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Mar 2027, 36 months later.
Of 99 non-industry observational studies under Kidney Diseases, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 33. This study's planned 36 months is below that.
Counting every sponsor, half of 116 studies reached it within 59 months; a quarter within 28 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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