xml: <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/NCT06018064</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002288</org_study_id>
      <nct_id>NCT06018064</nct_id>
    </id_info>
    <brief_title>Investigating Fit and Satisfaction of the Prone Positioner</brief_title>
    <official_title>Investigating the Fit and Satisfaction of an Innovative Device - Prone to Excellence: A Tummy Time Device Prone Positioner for Infants With Medical Complexities Including Artificial Airways: A Design Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the use of the Prone Positioner in&#xD;
        pediatric patients with tracheostomies (trachs). The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  What is the fit and satisfaction of the device?&#xD;
  &#xD;
          -  Does the device fulfill the goal of allowing infants with trachs participate in tummy&#xD;
             time&#xD;
  &#xD;
          -  What aesthetic feedback will the study team receive on the prone positioner from&#xD;
             families, therapists, and nursing staff.&#xD;
  &#xD;
        Participants will be placed in the Prone Positioner, they will be monitored for their&#xD;
        comfort/satisfaction with use, and how well they are able to be receive ventilation while in&#xD;
        the device. Parents of these infants, as well as healthcare providers, will be surveyed on&#xD;
        thoughts/suggestions for the Prone Positioner.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A trained member of this study staff will be always present in the patient room during the&#xD;
        fit test. For the fit test, a therapist from the study team will takes measurements of the&#xD;
        infant and then place the infant in the prone positioner device. At no time will the baby be&#xD;
        left alone or unsupported by staff. The study team will assess the physical fit, ease of&#xD;
        getting the infant in and out of the device, and the patient's tolerance to being in the&#xD;
        positioner.&#xD;
  &#xD;
        Parents/guardians will be able to be present while the patient is in the device (if the&#xD;
        parents are available and present at the time of fit testing) and immediately following the&#xD;
        patient's removal from the device, the parents will be asked to complete a paper survey. The&#xD;
        survey will ask for their perceptions of the device, initial reactions, and other qualitative&#xD;
        data collected during the fit test. Healthcare providers who are not part of the study team&#xD;
        will also be surveyed to obtain their thoughts/opinions on the device as well.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Infants between the ages &gt;44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fit and Size of Prone Positioner</measure>
      <time_frame>45 minutes</time_frame>
      <description>Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Parental Satisfaction with Prone Positioner</measure>
      <time_frame>Post patient use of positioner, survey to take a maximum of 10 minutes</time_frame>
      <description>Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Improvement in Positioning Needs of Patients</measure>
      <time_frame>Observed during the 45 min when patient is in Prone Positioner</time_frame>
      <description>Evaluate if the current prone positioner design improves positioning needs of patients who have tracheostomies and are ventilator dependent</description>
    </other_outcome>
    <other_outcome>
      <measure>Aesthetic and Usability Feedback of Prone Positioner</measure>
      <time_frame>Post patient use of positioner, survey to take a maximum of 10 minutes</time_frame>
      <description>Gather aesthetic and usability feedback on the prone positioner from families, therapists, and nursing staff</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Infant Development</condition>
    <arm_group>
      <arm_group_label>Interventional Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects who are placed in the Prone Positioner for evaluation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Prone Positioner</intervention_name>
      <description>An innovative device to allow for infants to be supported while in the prone position</description>
      <arm_group_label>Interventional Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal&#xD;
               Intensive Care Unit (NICU) with tracheostomies between the ages of &gt;44 weeks&#xD;
               gestational age to 18 months of age with various size/weights of infants.&#xD;
  &#xD;
            -  Any race/ethnicity&#xD;
  &#xD;
            -  English speaker&#xD;
  &#xD;
            -  Males and females&#xD;
  &#xD;
            -  Caregivers&#xD;
  &#xD;
            -  Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech&#xD;
               Therapists (STs) who have not seen the new prone positioner device.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants &gt; 18 months of age&#xD;
  &#xD;
            -  Infants medically unstable as determined by attending physician in the PICU/NICU&#xD;
  &#xD;
            -  Infants with recent cardiac or abdominal surgery who have precautions or complications&#xD;
               related to their surgery.&#xD;
  &#xD;
            -  Infants with weightbearing restrictions/fractures in their upper extremities.&#xD;
  &#xD;
            -  Non-English speakers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>44 Weeks</minimum_age>
      <maximum_age>18 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brandi Dorton, DPT, NTMTC</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Mercy Kansas City</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brandi Dorton, DPT, NTMTC</last_name>
      <phone>8162343380</phone>
      <email>bbdorton@cmh.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jennifer A Marshall, MPH, RN</last_name>
      <email>jamarshall@cmh.edu</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Hewitt L, Stanley RM, Okely AD. Correlates of tummy time in infants aged 0-12 months old: A systematic review. Infant Behav Dev. 2017 Nov;49:310-321. doi: 10.1016/j.infbeh.2017.10.001. Epub 2017 Nov 2.</citation>
      <PMID>29096238</PMID>
    </results_reference>
    <results_reference>
      <citation>Rocha NA, Tudella E. The influence of lying positions and postural control on hand-mouth and hand-hand behaviors in 0-4-month-old infants. Infant Behav Dev. 2008 Jan;31(1):107-14. doi: 10.1016/j.infbeh.2007.07.004. Epub 2007 Aug 17.</citation>
      <PMID>17707512</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>Brandi Dorton</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual Participant Data (IPD) elements will only be made available to the study team within Children's Mercy Kansas City. These IPD will be protected to greatest extent possible by the study team through the use of encrypted files and password protected sign-ons.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018064
  org study id: STUDY00002288
  nct id: NCT06018064
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the use of the Prone Positioner in
        pediatric patients with tracheostomies (trachs). The main question[s] it aims to answer are:
  
          -  What is the fit and satisfaction of the device?
  
          -  Does the device fulfill the goal of allowing infants with trachs participate in tummy
             time
  
          -  What aesthetic feedback will the study team receive on the prone positioner from
             families, therapists, and nursing staff.
  
        Participants will be placed in the Prone Positioner, they will be monitored for their
        comfort/satisfaction with use, and how well they are able to be receive ventilation while in
        the device. Parents of these infants, as well as healthcare providers, will be surveyed on
        thoughts/suggestions for the Prone Positioner.
  A trained member of this study staff will be always present in the patient room during the
        fit test. For the fit test, a therapist from the study team will takes measurements of the
        infant and then place the infant in the prone positioner device. At no time will the baby be
        left alone or unsupported by staff. The study team will assess the physical fit, ease of
        getting the infant in and out of the device, and the patient's tolerance to being in the
        positioner.
  
        Parents/guardians will be able to be present while the patient is in the device (if the
        parents are available and present at the time of fit testing) and immediately following the
        patient's removal from the device, the parents will be asked to complete a paper survey. The
        survey will ask for their perceptions of the device, initial reactions, and other qualitative
        data collected during the fit test. Healthcare providers who are not part of the study team
        will also be surveyed to obtain their thoughts/opinions on the device as well.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Infants between the ages >44 weeks gestational age to 18 months of age with complex medical conditions, particularly those with tracheostomies
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Fit and Size of Prone Positioner
  time frame: 45 minutes
  description: Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
  measure: Parental Satisfaction with Prone Positioner
  time frame: Post patient use of positioner, survey to take a maximum of 10 minutes
  description: Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?)
  measure: Improvement in Positioning Needs of Patients
  time frame: Observed during the 45 min when patient is in Prone Positioner
  description: Evaluate if the current prone positioner design improves positioning needs of patients who have tracheostomies and are ventilator dependent
  measure: Aesthetic and Usability Feedback of Prone Positioner
  time frame: Post patient use of positioner, survey to take a maximum of 10 minutes
  description: Gather aesthetic and usability feedback on the prone positioner from families, therapists, and nursing staff
  arm group label: Interventional Arm
  arm group type: Experimental
  description: Subjects who are placed in the Prone Positioner for evaluation
  intervention type: Device
  intervention name: Prone Positioner
  description: An innovative device to allow for infants to be supported while in the prone position
  arm group label: Interventional Arm
  criteria: 
  gender: All
  minimum age: 44 Weeks
  maximum age: 18 Months
  healthy volunteers: No
  last name: Brandi Dorton, DPT, NTMTC
  role: Principal Investigator
  affiliation: Children's Mercy Kansas City
  last name: Brandi Dorton, DPT, NTMTC
  phone: 8162343380
  email: bbdorton@cmh.edu
  last name: Jennifer A Marshall, MPH, RN
  email: jamarshall@cmh.edu
  citation: Hewitt L, Stanley RM, Okely AD. Correlates of tummy time in infants aged 0-12 months old: A systematic review. Infant Behav Dev. 2017 Nov;49:310-321. doi: 10.1016/j.infbeh.2017.10.001. Epub 2017 Nov 2.
  PMID: 29096238
  citation: Rocha NA, Tudella E. The influence of lying positions and postural control on hand-mouth and hand-hand behaviors in 0-4-month-old infants. Infant Behav Dev. 2008 Jan;31(1):107-14. doi: 10.1016/j.infbeh.2007.07.004. Epub 2007 Aug 17.
  PMID: 17707512
  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Brandi Dorton
  investigator title: Principal Investigator
  sharing ipd: No
  ipd description: Individual Participant Data (IPD) elements will only be made available to the study team within Children's Mercy Kansas City. These IPD will be protected to greatest extent possible by the study team through the use of encrypted files and password protected sign-ons.