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Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study

Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02148081
Enrollment
182
Registered
2014-05-28
Start date
2014-08-31
Completion date
2016-08-31
Last updated
2018-08-17

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

Conditions

Pediatric Critical Illness

Keywords

pediatrics, critical illness, recovery, function, health

Brief summary

When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. The specific objective of this research project is to evaluate how children and their families recover after a critical illness. Research Hypotheses: Following a critical illness in children, 1) the rate and degree of health and functional recovery is influenced by the following factors: age, pre-admission co-morbid status, critical illness severity, discharge functional status, and time to initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and health-related quality-of-life (HRQoL).

Detailed description

The Specific Objective of this study is to evaluate the trajectory of health and functional outcomes in children following a critical illness, define poor functional recovery, and evaluate predictors of poor recovery. The Research Questions for this study are: 1) What are the health and functional outcomes in children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of poor functional recovery in critically ill children? 4) What are the most important and relevant outcomes in critically ill children, from the patient and caregiver's point of view? Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London Health Sciences Centre.

Interventions

None listed

Sponsors

McMaster Children's Hospital
CollaboratorOTHER
London Health Sciences Centre
CollaboratorOTHER
Canadian Critical Care Trials Group
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Months to 17 Years
Healthy volunteers
No

Inclusion criteria

* Age over 12 months to 17 years * Admitted to PICU for at least 48 hours * ≥ one organ dysfunction on admission * Informed consent of patient/substitute decision maker, and patient assent were appropriate

Exclusion criteria

* Patients transferred directly from a neonatal intensive care unit prior to discharge home * Patients who are already mobilizing well, or are at baseline functional status at time of screening * Previous enrolment into this study * Language barrier (i.e. no access to translation services)

Design outcomes

Primary

MeasureTime frameDescription
Functional RecoveryIn the first 6 months following Pediatric Intensive Care Unit DischargeFunctional Status will be measured at PICU discharge, 3 and 6 months post discharge using the following measurement tools: Pediatric Evaluation of Disability Inventory (PEDI), and the Participation and Environment Measure - children and youth versions (PEM-CY/YC-PEM).
Predictors of Functional Recovery6 months post PICU dischargeThe following hypothesized determinants of functional recovery will be evaluated: age, critical illness severity, pre-admission co-morbid status, PICU discharge functional status, and time to rehabilitation.

Secondary

MeasureTime frameDescription
Additional components of functional healthThe first 6 months post PICU dischargeFunctional Health Status will be measured using the International Classification of Functioning, Disability and Health (ICF) framework (www.who.int/icidh/). In addition to the primary outcome measurements, the following will be assessed: Caregiver burden using the Pediatric Inventory for Parents; and Health Related Quality of Life using KIDSCREEN. The following secondary outcomes of interest will also be measured: Short-term PICU outcomes (i.e. duration of ventilation, length of stay, severity of organ dysfunction, morbidities attributable to delayed mobilization); mortality, health care utilization, and Pediatric Cerebral performance category and Pediatric Overall Performance scores in the 6 months post PICU discharge.

Other

MeasureTime frameDescription
Audit of Patient Centeredness of Outcomes6 months post PICU dischargeQualitative methodology will be used in this study to understand what is important to patients and families following survival from a critical illness, and if our selected outcomes of interest for this study are aligned with what patients and families consider meaningful and important. Patient and caregiver interviews will be conducted for this purpose in the 6 months following PICU discharge

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026