- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148081
Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study
Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital
-
London, Ontario, Canada
- Children's Hospital London Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Critically ill children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Recovery
Time Frame: 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).
|
In the first 6 months following Pediatric Intensive Care Unit Discharge
|
Predictors of Functional Recovery
Time Frame: 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.
|
6 months post PICU discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional components of functional health
Time Frame: 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.
|
The first 6 months post PICU discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Audit of Patient Centeredness of Outcomes
Time Frame: 6 months post PICU discharge
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Choong, MB, BCh, MSc, McMaster University; Canadian Critical Care Trials Group
Publications and helpful links
General Publications
- Jarvis JM, Fayed N, Fink EL, Choong K, Khetani MA. Caregiver dissatisfaction with their child's participation in home activities after pediatric critical illness. BMC Pediatr. 2020 Sep 2;20(1):415. doi: 10.1186/s12887-020-02306-3.
- Jarvis JM, Gurga AR, Lim H, Cameron J, Gorter JW, Choong K, Khetani MA. Caregiver Strategy Use to Promote Children's Home Participation After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Nov;100(11):2144-2150. doi: 10.1016/j.apmr.2019.05.034. Epub 2019 Jul 3.
- Jarvis JM, Choong K, Khetani MA. Associations of Participation-Focused Strategies and Rehabilitation Service Use With Caregiver Stress After Pediatric Critical Illness. Arch Phys Med Rehabil. 2019 Apr;100(4):703-710. doi: 10.1016/j.apmr.2018.11.017. Epub 2018 Dec 19.
- Khetani MA, Albrecht EC, Jarvis JM, Pogorzelski D, Cheng E, Choong K. Determinants of change in home participation among critically ill children. Dev Med Child Neurol. 2018 Aug;60(8):793-800. doi: 10.1111/dmcn.13731. Epub 2018 Mar 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Critical Illness
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Boston Children's HospitalCompleted
-
Ann & Robert H Lurie Children's Hospital of ChicagoRecruitingCritical Illness | Pediatric | ConsentUnited States
-
Assistance Publique - Hôpitaux de ParisRecruitingPediatric Intensive Care Unit | Pediatric Immuno-hematology DepartmentFrance
-
Göteborg UniversityNot yet recruitingCritical Illness | Pediatric Disorder | Ethics, Narrative
-
Azienda Ospedaliera di PadovaUniversity of PadovaCompletedCritically Ill | Pediatric CancerItaly
-
University of PittsburghRecruitingCritical Illness | Dysbiosis | Pediatric ALLUnited States
-
Hospices Civils de LyonRecruitingPediatric ALL | Fasting | AspirationFrance
-
KK Women's and Children's HospitalUniversity of PlymouthActive, not recruitingCritical Illness | Pediatric ALL | Post Intensive Care Unit SyndromeSingapore
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States