Outcomes of Children After Hospitalization in Intensive Care Unit (NCT06124092) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Outcomes of Children After Hospitalization in Intensive Care Unit
Canada690 participantsStarted 2024-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on tracking what happens to children after a PICU stay — including those admitted for conditions like sepsis, pneumonia, or heart disease — would my child's specific diagnosis make them a relevant candidate to discuss with you once enrollment opens?
2This trial isn't recruiting yet, so if my child is discharged from the PICU soon, is there any way to be notified when it starts, or would the timing of discharge affect whether we could even participate?
3The study is trying to identify risk factors for something called PICS-p — post-intensive care syndrome in children — at 2 months after PICU discharge. Can you explain what PICS-p is and whether my child might already be at risk for it based on what they've been through?
4Since this is an observational study measuring outcomes rather than testing a treatment, does participating mean my child would receive any different care, or would it mainly involve follow-up assessments after they leave the PICU?
5Are there standard follow-up programs or rehabilitation services available right now to support children after a PICU stay, even outside of this trial, given that it hasn't started recruiting yet?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify risk factors of PICS-p at 2 months post-PICU
Timeframe: 2 months after PICU discharge
2
Develop and validate a model predictive of PICS-p 2 months post PICU