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NCT Number: NCT02148081

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

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Key information

Conditions

Pediatric Critical Illness Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Critical Care Trials Group
  • London Health Sciences Centre
  • McMaster Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 28, 2014
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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