Outcomes of Children After Hospitalization in Intensive Care Unit

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorSt. Justine's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children ≤18yo hospitalized in PICU for ≥96 hours

Disqualifiers

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).

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • neurocognitive tests

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

1

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

Sponsors and contacts

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St. Justine's Hospital

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: