<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01724593</url>
  </required_header>
  <id_info>
    <org_study_id>HHS REB No. 12-475</org_study_id>
    <nct_id>NCT01724593</nct_id>
  </id_info>
  <brief_title>Functional Recovery in Critically Ill Children</brief_title>
  <official_title>Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karen Choong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and&#xD;
      preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is&#xD;
      associated with increased mortality and length of stay, and negatively impacts long-term&#xD;
      functional outcomes and quality of life in affected patients and their caregivers. While&#xD;
      delayed mobilization adversely affects clinical outcomes, early rehabilitation in the&#xD;
      critically ill adult population is safe, feasible, cost effective, results in more ventilator&#xD;
      free-days and better functional outcomes at hospital discharge. In contrast, there is a&#xD;
      paucity of this research in pediatrics. Our research suggests that immobilization is common&#xD;
      in critically ill children, and rehabilitation is delayed particularly in the sickest&#xD;
      children who are arguably at highest risk of morbidity. It is unclear however, whether&#xD;
      delayed rehabilitation leads to adverse outcomes in critically ill children, as has been&#xD;
      demonstrated in adults. Our objectives of this study are to evaluate if immobilization and&#xD;
      delayed rehabilitation negatively impacts short-term clinical outcomes and the time to&#xD;
      functional recovery in critically ill children. The investigators hypothesize that the&#xD;
      following factors may influence functional recovery and morbidity in critically ill children:&#xD;
&#xD;
        -  Pre-morbid condition&#xD;
&#xD;
        -  Age&#xD;
&#xD;
        -  Time-to-initiation of acute rehabilitation&#xD;
&#xD;
        -  Critical illness disease severity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall Study objectives:&#xD;
&#xD;
        1. To describe the functional recovery following prolonged immobility and delayed&#xD;
           rehabilitation in critically ill children.&#xD;
&#xD;
        2. To explore the predictors of impaired functional recovery following immobilization in&#xD;
           critically ill children.&#xD;
&#xD;
      Prior to conducting a definitive multi-centre study to answer our research questions and&#xD;
      achieve our study objectives above, we will conduct a pilot study in order to demonstrate&#xD;
      feasibility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>12 months</time_frame>
    <description>Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Recovery</measure>
    <time_frame>Baseline, 3 and 6 month follow-up</time_frame>
    <description>Functional Recovery will be measured by the following standardized, validate pediatric assessment tools of function, as defined by the International Classification of Functioning, Disability and Health (ICF): 1) Pediatric Evaluation of Disability Inventory (PEDI); 2) Participation and Environment Measure - children and youth version (PEM-CY), and preschool version; 3) Pediatric Overall Performance Category score (POPC); 4) Pediatric Cerebral Performance Category Score (PCPC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Critical care Unit (PCCU) clinical outcomes</measure>
    <time_frame>at 30 days and duration of hospitalization</time_frame>
    <description>PCCU outcomes will be assessed by the following: Ventilator-free days, PCCU mortality, length of PCCU and hospital stay, and the incidence of PCCU-acquired weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>Hospital discharge and at 3 and 6 month follow-up</time_frame>
    <description>In an age-appropriate subgroup, the following measurements will be conducted:&#xD;
Muscle Strength and aerobic fitness testing (age ≥ 5 years, and/or able to cognitively and physically comply with strength and fitness tests)&#xD;
Measurement of muscle strength using BIODEX and hand grip strength, and assessment of lean mass (Bioelectrical impedance analysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental or caregiver stress</measure>
    <time_frame>3 month follow-up</time_frame>
    <description>Parental or caregiver stress will be measured with the Parental Stress Index (PSI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility and reliability of screening for PCCU-acquired weakness</measure>
    <time_frame>Duration of Hospitalization, 3 and 6 months follow-up</time_frame>
    <description>The most appropriate method of screening and diagnosing PCCU-acquired weakness has not been well established given the many challenges in ascertainment in this population. Hence, one of the objectives of this study is to determine whether manual muscle strength testing is a feasible and reliable method of screening for this important disorder in the critically ill pediatric population. Muscle strength will be quantified clinically using the (MRC) score by 2 independent assessors. For a subset of age appropriate (≥ 4 years), we will determine their hand-grip strength using a hand dynamometer or Martin Vigorimeter, depending on their age.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Critical Illness</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Observational Cohort</arm_group_label>
    <description>No Intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Critically Ill Children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 12 months to 17 years&#xD;
&#xD;
          -  PCCU stay of ≥ 48 hours&#xD;
&#xD;
          -  Patient is limited to bed-rest and has not been mobilized during the first 48 hours of&#xD;
             PCCU admission&#xD;
&#xD;
          -  Equal to or greater than one organ dysfunction on PCCU admission (as measured by&#xD;
             PELOD)&#xD;
&#xD;
          -  Informed consent of patient/substitute decision maker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: &lt; 12 months or ≥18 years&#xD;
&#xD;
          -  Patients admitted to step-down/intermediate care&#xD;
&#xD;
          -  Patients transferred from Neonatal intensive care unit and never discharge home.&#xD;
&#xD;
        iv) Patients who are already mobilizing well, or are at baseline functional status at time&#xD;
        of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré&#xD;
        Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi)&#xD;
        Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6&#xD;
        months ago and/or still undergoing study procedures at time of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Choong, MB, BCh, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 3, 2013</last_update_submitted>
  <last_update_submitted_qc>November 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Karen Choong</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>functional recovery, critical illness, pediatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01724593
org study id: HHS REB No. 12-475
nct id: NCT01724593
lead sponsor: 
has dmc: No
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
Overall Study objectives:

        1. To describe the functional recovery following prolonged immobility and delayed
           rehabilitation in critically ill children.

        2. To explore the predictors of impaired functional recovery following immobilization in
           critically ill children.

      Prior to conducting a definitive multi-centre study to answer our research questions and
      achieve our study objectives above, we will conduct a pilot study in order to demonstrate
      feasibility.
observational model: Cohort
time perspective: Prospective
measure: Feasibility
time frame: 12 months
description: Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.
measure: Functional Recovery
time frame: Baseline, 3 and 6 month follow-up
description: Functional Recovery will be measured by the following standardized, validate pediatric assessment tools of function, as defined by the International Classification of Functioning, Disability and Health (ICF): 1) Pediatric Evaluation of Disability Inventory (PEDI); 2) Participation and Environment Measure - children and youth version (PEM-CY), and preschool version; 3) Pediatric Overall Performance Category score (POPC); 4) Pediatric Cerebral Performance Category Score (PCPC)
measure: Pediatric Critical care Unit (PCCU) clinical outcomes
time frame: at 30 days and duration of hospitalization
description: PCCU outcomes will be assessed by the following: Ventilator-free days, PCCU mortality, length of PCCU and hospital stay, and the incidence of PCCU-acquired weakness
measure: Muscle Strength
time frame: Hospital discharge and at 3 and 6 month follow-up
description: In an age-appropriate subgroup, the following measurements will be conducted:
Muscle Strength and aerobic fitness testing (age ≥ 5 years, and/or able to cognitively and physically comply with strength and fitness tests)
Measurement of muscle strength using BIODEX and hand grip strength, and assessment of lean mass (Bioelectrical impedance analysis)
measure: Parental or caregiver stress
time frame: 3 month follow-up
description: Parental or caregiver stress will be measured with the Parental Stress Index (PSI)
measure: Feasibility and reliability of screening for PCCU-acquired weakness
time frame: Duration of Hospitalization, 3 and 6 months follow-up
description: The most appropriate method of screening and diagnosing PCCU-acquired weakness has not been well established given the many challenges in ascertainment in this population. Hence, one of the objectives of this study is to determine whether manual muscle strength testing is a feasible and reliable method of screening for this important disorder in the critically ill pediatric population. Muscle strength will be quantified clinically using the (MRC) score by 2 independent assessors. For a subset of age appropriate (≥ 4 years), we will determine their hand-grip strength using a hand dynamometer or Martin Vigorimeter, depending on their age.
arm group label: Observational Cohort
description: No Intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 17 Years
healthy volunteers: No
last name: Karen Choong, MB, BCh, MSc
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: McMaster University
investigator full name: Karen Choong
investigator title: Associate Professor
mesh term: Critical Illness