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

Completed

• Conditions: Pediatric Critical Illness

• Registration Number: NCT02148081
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Study Start: 2014-08
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Recovery	In the first 6 months following Pediatric Intensive Care Unit Discharge	Functional 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 Recovery	6 months post PICU discharge	The 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 Outcome Measures

Name	Time	Method
Additional components of functional health	The first 6 months post PICU discharge	Functional 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.

Trial Locations

Locations (2)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital London Health Sciences; 🇨🇦 London, Ontario, Canada