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/NCT06039852</url>
    </required_header>
    <id_info>
      <org_study_id>288217</org_study_id>
      <nct_id>NCT06039852</nct_id>
    </id_info>
    <brief_title>Acceptability and Feasibility of a New Postural Management Night-time Intervention to Improve Respiratory Health of Children With Complex Neuro-disability</brief_title>
    <acronym>Breathe-Easy</acronym>
    <official_title>Breathe-Easy: a Pilot Study to Examine the Acceptability and Feasibility of a Novel Postural Management Night-time Intervention to Improve Respiratory Health of Children With Complex Neuro-disability.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sussex Community NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sussex Community NHS Foundation Trust</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>
        This research concerns children with complex neuro-disability. Damage to the developing brain&#xD;
        leads to lifelong disturbances in motor control, seizures, cognition, communication, eating&#xD;
        and drinking, and behaviour. Children with complex neuro-disability are dependent upon others&#xD;
        to move and position them. Children commonly experience chronic lung disease, leading to&#xD;
        frequent hospitalisation, medical interventions and premature death. Respiratory illness may&#xD;
        be triggered by &quot;aspiration&quot;, i.e. when saliva, food, liquid or stomach contents enter the&#xD;
        lungs. Aspiration risks increase at night-time when supervision is limited and children are&#xD;
        positioned on their backs. Some children experience repeated breathing complications&#xD;
        requiring prolonged hospital stays including respiratory support in intensive care.&#xD;
  &#xD;
        Consultant Respiratory Paediatrician Akshat Kapur and Physiotherapist Hilda Perry developed a&#xD;
        new night-time intervention to improve respiratory health of children with complex&#xD;
        neuro-disability. Dr Kapur and his team have found that this intervention can help reduce&#xD;
        respiratory illness and time spent in hospital for some children. This is an acceptability&#xD;
        and feasibility study which means we want to find out if this new intervention is something&#xD;
        that children with complex neuro-disability and their families are happy (i.e. it is&#xD;
        acceptable) and able (i.e. it is feasible) to do. If so, a larger future research study can&#xD;
        be designed to find out if the intervention works to improve the respiratory health of&#xD;
        children with complex neuro-disability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The intervention involves positioning children safely on their fronts using pillows to&#xD;
        support the body under the shoulder and hip, and with the head slightly lowered so that&#xD;
        gravity can help drain secretions from the mouth. This is different to current night-time&#xD;
        positioning recommendations of either lying children on their backs or side. The new&#xD;
        intervention also involves, where possible, the draining of children's stomach contents&#xD;
        overnight via an existing feeding tube to prevent aspiration of stomach contents.&#xD;
  &#xD;
        We will work closely with 10 children with complex neuro-disability and their families, and&#xD;
        health professionals as we introduce this new night-time intervention. We will make&#xD;
        observations about children's respiratory and sleep outcomes before and after making changes.&#xD;
        We will make comparisons using questionnaires, sleep diaries, records of antibiotic use and&#xD;
        hospital admissions. We will collect this information before making any changes, at 3 months&#xD;
        after the intervention has been established and after 6 months when the study ends. We will&#xD;
        talk to children, parents, carers and relevant health professionals to find out what they&#xD;
        think and feel about the new intervention, including any issues/challenges that occurred.&#xD;
  &#xD;
        We will record how many children and families were approached to take part in the study. We&#xD;
        will record how many agreed to take part, how many chose to leave half way through and how&#xD;
        many said they did not want to take part in the study. Families who discontinued or who&#xD;
        declined the intervention will be given opportunity to provide feedback confidentially.&#xD;
  &#xD;
        We will use the findings to decide whether it is feasible and acceptable to children and&#xD;
        families to run a research trial of this new night-time intervention. The data will help us&#xD;
        to design a future research trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 1, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Liverpool Respiratory Symptom Questionnaire</measure>
      <time_frame>2 years</time_frame>
      <description>Questionnaire Outcome Measure</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Respiratory Aspiration</condition>
    <arm_group>
      <arm_group_label>Novel Postural Management Night-time Intervention Components</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention Arm</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Novel Postural Management Night-time Intervention</intervention_name>
      <description>Essential elements and components of PMN-TI:&#xD;
  Safe and comfortable position to enable sleep&#xD;
  Positioning to enable UAD overnight&#xD;
  Quiet breathing unobstructed by base of tongue (i.e. stertor), vocal cords (i.e. stridor) or pooled secretions&#xD;
  Postural support in lying to achieve comfort, promote symmetry of posture and maximum loadbearing&#xD;
  Stomach contents reduced or emptied overnight to minimize reflux and associated aspiration risk.</description>
      <arm_group_label>Novel Postural Management Night-time Intervention Components</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  dependent upon others to position/move their bodies&#xD;
  &#xD;
            -  high risk of aspiration linked to swallowing difficulties&#xD;
  &#xD;
            -  aged 2-18yrs&#xD;
  &#xD;
            -  have gastrostomy/jejunostomy&#xD;
  &#xD;
            -  receiving care from Consultant Respiratory Paediatrician from Royal Alexandra&#xD;
               Children's Hospital (Dr Kapur or colleague) because of recent history of chest&#xD;
               infections.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with complex neuro-disability who cannot be positioned in such a way that&#xD;
               promotes upper airway drainage&#xD;
  &#xD;
            -  Children using a naso-gastric tube&#xD;
  &#xD;
            -  Children who do not have a gastrostomy or jejunostomy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah Crombie, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sussex Community NHS FT</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chailey Clinical Services</name>
        <address>
          <city>Brighton</city>
          <state>East Sussex</state>
          <zip>BN8 4JN</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06039852
  org study id: 288217
  nct id: NCT06039852
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research concerns children with complex neuro-disability. Damage to the developing brain
        leads to lifelong disturbances in motor control, seizures, cognition, communication, eating
        and drinking, and behaviour. Children with complex neuro-disability are dependent upon others
        to move and position them. Children commonly experience chronic lung disease, leading to
        frequent hospitalisation, medical interventions and premature death. Respiratory illness may
        be triggered by "aspiration", i.e. when saliva, food, liquid or stomach contents enter the
        lungs. Aspiration risks increase at night-time when supervision is limited and children are
        positioned on their backs. Some children experience repeated breathing complications
        requiring prolonged hospital stays including respiratory support in intensive care.
  
        Consultant Respiratory Paediatrician Akshat Kapur and Physiotherapist Hilda Perry developed a
        new night-time intervention to improve respiratory health of children with complex
        neuro-disability. Dr Kapur and his team have found that this intervention can help reduce
        respiratory illness and time spent in hospital for some children. This is an acceptability
        and feasibility study which means we want to find out if this new intervention is something
        that children with complex neuro-disability and their families are happy (i.e. it is
        acceptable) and able (i.e. it is feasible) to do. If so, a larger future research study can
        be designed to find out if the intervention works to improve the respiratory health of
        children with complex neuro-disability.
  The intervention involves positioning children safely on their fronts using pillows to
        support the body under the shoulder and hip, and with the head slightly lowered so that
        gravity can help drain secretions from the mouth. This is different to current night-time
        positioning recommendations of either lying children on their backs or side. The new
        intervention also involves, where possible, the draining of children's stomach contents
        overnight via an existing feeding tube to prevent aspiration of stomach contents.
  
        We will work closely with 10 children with complex neuro-disability and their families, and
        health professionals as we introduce this new night-time intervention. We will make
        observations about children's respiratory and sleep outcomes before and after making changes.
        We will make comparisons using questionnaires, sleep diaries, records of antibiotic use and
        hospital admissions. We will collect this information before making any changes, at 3 months
        after the intervention has been established and after 6 months when the study ends. We will
        talk to children, parents, carers and relevant health professionals to find out what they
        think and feel about the new intervention, including any issues/challenges that occurred.
  
        We will record how many children and families were approached to take part in the study. We
        will record how many agreed to take part, how many chose to leave half way through and how
        many said they did not want to take part in the study. Families who discontinued or who
        declined the intervention will be given opportunity to provide feedback confidentially.
  
        We will use the findings to decide whether it is feasible and acceptable to children and
        families to run a research trial of this new night-time intervention. The data will help us
        to design a future research trial.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Liverpool Respiratory Symptom Questionnaire
  time frame: 2 years
  description: Questionnaire Outcome Measure
  arm group label: Novel Postural Management Night-time Intervention Components
  arm group type: Experimental
  description: Intervention Arm
  intervention type: Other
  intervention name: Novel Postural Management Night-time Intervention
  description: Essential elements and components of PMN-TI:
  Safe and comfortable position to enable sleep
  Positioning to enable UAD overnight
  Quiet breathing unobstructed by base of tongue (i.e. stertor), vocal cords (i.e. stridor) or pooled secretions
  Postural support in lying to achieve comfort, promote symmetry of posture and maximum loadbearing
  Stomach contents reduced or emptied overnight to minimize reflux and associated aspiration risk.
  arm group label: Novel Postural Management Night-time Intervention Components
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Sarah Crombie, PhD
  role: Principal Investigator
  affiliation: Sussex Community NHS FT
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Respiratory Aspiration
  sharing ipd: No