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

Pediatric Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148081
• Other study ID #: 14-214
• Status: Completed
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Pediatric Critical Illness

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital London Health Sciences	London	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Critical Care Trials Group, London Health Sciences Centre, McMaster Children's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Audit of Patient Centeredness of Outcomes	Qualitative 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	6 months post PICU discharge
Primary	Functional Recovery	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).	In the first 6 months following Pediatric Intensive Care Unit Discharge
Primary	Predictors of Functional Recovery	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.	6 months post PICU discharge
Secondary	Additional components of functional health	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.	The first 6 months post PICU discharge