<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/NCT02209935</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI APDTO</org_study_id>
    <nct_id>NCT02209935</nct_id>
  </id_info>
  <brief_title>RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury</brief_title>
  <official_title>RCT Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background. Early rehabilitation programs (ERP) that include physical, occupational, and&#xD;
      speech therapies lessens debilitation and promotes return to previous physical and cognitive&#xD;
      functioning and have been successfully applied in adult intensive care units (ICUs). Despite&#xD;
      the fact that critically ill children with acute brain injury (ABI) are at increased risk of&#xD;
      life-long disability and stunted development, benefits of ERP for this group have not been&#xD;
      studied and are not standard of care in pediatric ICUs.&#xD;
&#xD;
      Objectives. The aims of this study are 1) To better understand current practices and barriers&#xD;
      to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with&#xD;
      ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that&#xD;
      ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be&#xD;
      superior compared to the usual care group.&#xD;
&#xD;
      Methods. The first task of this research program is to survey healthcare professionals&#xD;
      (physicians, nurses, allied health) and families of children in the ICU about their&#xD;
      hospital's resources, current practices, and barriers to ERP. This survey will be distributed&#xD;
      to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators&#xD;
      (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from&#xD;
      critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled&#xD;
      trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of&#xD;
      ICU admission and those in the usual care group will begin therapies when these services are&#xD;
      ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to&#xD;
      the ICU &gt; 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are&#xD;
      eligible. Therapy interventions are individualized for the child's clinical status. The&#xD;
      effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS)&#xD;
      pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical&#xD;
      and cognitive function as well as behavior. Other tests will be performed that assesses child&#xD;
      and family quality of life and length of hospital admission. Our outcome tests were chosen&#xD;
      because 1) They are the most important outcomes to families of children as surveyed in our&#xD;
      ICU and 2) They are outcomes that can be influenced by ERP.&#xD;
&#xD;
      Summary. This is the first and largest study designed to evaluate whether ERP improves&#xD;
      outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in&#xD;
      ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will&#xD;
      have superior adaptive and quality of life outcomes, outcomes important to families, without&#xD;
      increasing adverse events compared to patients in the usual care group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vineland Adaptive Behavioral Scale score</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Typically, usual care is when therapies are not initiated until the treating team places an order for each element of care (physical, occupational, speech, and emotional therapy consultation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Rehabilitation Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical, occupational, speech, and emotional evaluation and support personalized to the subject's severity of illness and developmental status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Rehabilitation Protocol</intervention_name>
    <arm_group_label>Early Rehabilitation Protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 3-17 years&#xD;
&#xD;
          -  ABI due to TBI, ischemia, CNS infection / inflammation (i.e., meningitis,&#xD;
             encephalitis), or cardiac arrest&#xD;
&#xD;
          -  Subjects will be enrolled prior to 48 hours of PICU admission, have English or Spanish&#xD;
             speaking parents/guardians, and en expected ICU stay ≥ 3 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with a do not resuscitate status&#xD;
&#xD;
          -  Pediatric Cerebral Performance Category (PCPC) score 4-5 (4=severe disability and&#xD;
             5=persistent vegetative state) prior to ABI or are not expected to survive &gt; 24 hours&#xD;
             will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Ericka Fink</investigator_full_name>
    <investigator_title>Associate Professor, Pediatric Critical Care Medicine</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>acute neurologic disease</keyword>
  <keyword>critical care</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Nervous System Diseases</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/NCT02209935
org study id: PCORI APDTO
nct id: NCT02209935
lead sponsor: 
collaborator: 
has dmc: Yes
Background. Early rehabilitation programs (ERP) that include physical, occupational, and
      speech therapies lessens debilitation and promotes return to previous physical and cognitive
      functioning and have been successfully applied in adult intensive care units (ICUs). Despite
      the fact that critically ill children with acute brain injury (ABI) are at increased risk of
      life-long disability and stunted development, benefits of ERP for this group have not been
      studied and are not standard of care in pediatric ICUs.

      Objectives. The aims of this study are 1) To better understand current practices and barriers
      to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with
      ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that
      ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be
      superior compared to the usual care group.

      Methods. The first task of this research program is to survey healthcare professionals
      (physicians, nurses, allied health) and families of children in the ICU about their
      hospital's resources, current practices, and barriers to ERP. This survey will be distributed
      to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators
      (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from
      critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled
      trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of
      ICU admission and those in the usual care group will begin therapies when these services are
      ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to
      the ICU > 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are
      eligible. Therapy interventions are individualized for the child's clinical status. The
      effectiveness of ERP will be measured using the Vineland Behavior Adaptive Scale (VABS)
      pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical
      and cognitive function as well as behavior. Other tests will be performed that assesses child
      and family quality of life and length of hospital admission. Our outcome tests were chosen
      because 1) They are the most important outcomes to families of children as surveyed in our
      ICU and 2) They are outcomes that can be influenced by ERP.

      Summary. This is the first and largest study designed to evaluate whether ERP improves
      outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in
      ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will
      have superior adaptive and quality of life outcomes, outcomes important to families, without
      increasing adverse events compared to patients in the usual care group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Vineland Adaptive Behavioral Scale score
time frame: 6 months
arm group label: Usual Care
arm group type: Active Comparator
description: Typically, usual care is when therapies are not initiated until the treating team places an order for each element of care (physical, occupational, speech, and emotional therapy consultation).
arm group label: Early Rehabilitation Protocol
arm group type: Experimental
description: Physical, occupational, speech, and emotional evaluation and support personalized to the subject's severity of illness and developmental status.
intervention type: Other
intervention name: Early Rehabilitation Protocol
arm group label: Early Rehabilitation Protocol
intervention type: Other
intervention name: Usual care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Ericka Fink
investigator title: Associate Professor, Pediatric Critical Care Medicine
mesh term: Brain Injuries
mesh term: Nervous System Diseases