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

NCT02148081 | Completed

• 1 other identifier: 14-214
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 2

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).

Conditions

Pediatric Critical Illness

Keywords

pediatrics, critical illness, recovery, function, health

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Additional components of functional health

  The first 6 months post PICU discharge

Other Outcomes (1)

• Audit of Patient Centeredness of Outcomes

  6 months post PICU discharge

Study Arms (1)

Critically ill children

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

In order to enrol children at potential risk for the outcomes of interest, and avoid "healthier" participants with short PICU stays, we considered the following: the patient should have: a) a minimum age (when one is expected to be ambulatory/mobilizing), and b) a threshold severity of illness. In order to understand how different subsets of PICU populations are affected by critical illness, we chose not to restrict the selection of patients to a specific diagnosis, nor did we exclude patients with underlying functional or cognitive abnormalities at baseline. This study will evaluate the epidemiology of recovery in a general critically ill pediatric population over time.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McMaster University: lead
• McMaster Children's Hospital: collaborator
• London Health Sciences Centre: collaborator
• Canadian Critical Care Trials Group: collaborator

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital London Health Sciences

London, Ontario, Canada

Location

Related Publications (4)

• 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.

  PMID: 32878614 DERIVED

• 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.

  PMID: 31278925 DERIVED

• 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.

  PMID: 30578773 DERIVED

• 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.

  PMID: 29574916 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Choong, MB, BCh, MSc

  McMaster University; Canadian Critical Care Trials Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 28, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

CA (2)