Functional Recovery in Critically Ill Children

NCT01724593 | Completed

• 1 other identifier: HHS REB No. 12-475
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children:

• Pre-morbid condition
• Age
• Time-to-initiation of acute rehabilitation
• Critical illness disease severity

Conditions

Critical Illness; Children

Keywords

functional recovery, critical illness, pediatrics

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.

  12 months

Secondary Outcomes (4)

• Functional Recovery

  Baseline, 3 and 6 month follow-up

• Pediatric Critical care Unit (PCCU) clinical outcomes

  at 30 days and duration of hospitalization

• Muscle Strength

  Hospital discharge and at 3 and 6 month follow-up

• Parental or caregiver stress

  3 month follow-up

Other Outcomes (1)

• Feasibility and reliability of screening for PCCU-acquired weakness

  Duration of Hospitalization, 3 and 6 months follow-up

Study Arms (1)

Observational Cohort

No Intervention

Eligibility Criteria

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

Study Population

Critically Ill Children

You may qualify if:

• Age over 12 months to 17 years
• PCCU stay of ≥ 48 hours
• Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission
• Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)
• Informed consent of patient/substitute decision maker.

You may not qualify if:

• Age: \< 12 months or ≥18 years
• Patients admitted to step-down/intermediate care
• Patients transferred from Neonatal intensive care unit and never discharge home.
• iv) Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening

Sponsors & Collaborators

• Karen Choong: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 12, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

CA (1)