<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/NCT02240134</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 276-13</org_study_id>
    <secondary_id>R01ES022649</secondary_id>
    <nct_id>NCT02240134</nct_id>
  </id_info>
  <brief_title>Wood Stove Interventions and Child Respiratory Health</brief_title>
  <acronym>KidsAIR</acronym>
  <official_title>Wood Stove Interventions and Child Respiratory Infections in Rural Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Montana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Montana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute lower respiratory tract infections (LRTIs) account for more than 27% of all&#xD;
      hospitalizations among US children under five years of age, with recurrent LRTIs in children&#xD;
      a recognized risk factor for asthma. Residential biomass combustion leads to elevated indoor&#xD;
      levels of fine particulate matter (PM2.5) that often exceed current health-based air quality&#xD;
      standards. PM2.5 exposure is associated with many adverse health outcomes, including a&#xD;
      greater than three-fold increased risk of LRTIs. To date, exposure reduction strategies in&#xD;
      wood stove homes have been either inconsistently effective or include factors that limit&#xD;
      widespread dissemination and continued compliance in rural and economically disadvantaged&#xD;
      populations. In this project, the investigators propose to test the efficacy of two&#xD;
      intervention strategies for reducing indoor wood smoke PM2.5 exposures and children's risk of&#xD;
      LRTI in three unique and underserved settings: (1) rural mountain valley communities in&#xD;
      western Montana; (2) Navajo Nation communities; and (3) Alaska Native Villages. The&#xD;
      investigators will conduct a three-arm randomized placebo-controlled post-only intervention&#xD;
      trial in wood stove homes with children less than five years old. Education on best-burn&#xD;
      practices and training on the use of simple instruments (i.e., stove thermometers and wood&#xD;
      moisture meters) will be introduced as one intervention arm (Tx1). This intervention will be&#xD;
      evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3,&#xD;
      sham air filters). The primary outcome will be LRTI incidence among children under five years&#xD;
      of age. To allow for detection of exposure and outcome differences within each of the three&#xD;
      regions, a sample of 324 homes, or 108 within each study area will be equally assigned to&#xD;
      each of the three intervention arms. The overall hypothesis is that a low-cost, educational&#xD;
      intervention targeting indoor wood smoke PM2.5 exposures will be sustainable, and can reduce&#xD;
      children's risk of LRTI in underserved Native and rural communities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rural and Native areas of the western United States (US) and Alaska experience substantial&#xD;
      exposure and health disparities compared to more populated urban centers. One such source of&#xD;
      disparity is the elevated inhalation exposures related to the use of wood stoves for home&#xD;
      heating. Within rural areas of Montana, Alaska, and the Navajo Nation, research has shown&#xD;
      that residential biomass combustion leads to indoor levels of fine particulate matter (PM2.5)&#xD;
      that often exceed current health-based air quality standards. Parallel findings have been&#xD;
      observed in several developing countries where biomass combustion is commonly used for&#xD;
      cooking and/or heating. This is concerning, as PM2.5 exposure is associated with many adverse&#xD;
      health outcomes, including a greater than three-fold increased risk of acute respiratory&#xD;
      tract infections. Throughout the world, lower respiratory tract infections (LRTIs) are the&#xD;
      most common cause of death in children under five years of age, and account for more than 27%&#xD;
      of all hospitalizations among US children under five years. Importantly, untoward effects of&#xD;
      recurrent LRTIs are cumulative in children and a recognized risk factor for asthma.&#xD;
&#xD;
      Currently, there is a global effort to reduce indoor biomass smoke exposures in developing&#xD;
      countries. A recent intervention trial found that exposure reductions following the&#xD;
      introduction of improved cookstoves was protective for severe infant pneumonia. Similar&#xD;
      evidence-based efforts are warranted in rural and Native American communities in the US that&#xD;
      suffer from elevated rates of childhood LRTI and commonly use wood for residential heating.&#xD;
      The investigators have previously demonstrated that a community-wide wood stove changeout&#xD;
      program (i.e., replacing old wood stoves with newer model wood stoves) resulted in reduced&#xD;
      wintertime ambient PM2.5 and corresponding reductions in occurrence of childhood wheeze and&#xD;
      respiratory infections. In this and other studies, however, inconsistent effects on indoor&#xD;
      air quality following the introduction of newer technology wood stoves have been observed.&#xD;
      The investigators have also shown that the introduction of air filtration units is a less&#xD;
      costly and more efficacious strategy for reducing indoor wood smoke exposures. Nevertheless,&#xD;
      the energy costs of operation and need for filter replacement (maintenance) remain barriers&#xD;
      to widespread dissemination and continued compliance in rural and economically disadvantaged&#xD;
      communities. Experience with these interventions and qualitative input from wood stove&#xD;
      experts suggest that educational interventions related to wood stove operation can translate&#xD;
      to low-cost and sustainable strategies that reduce indoor biomass combustion exposures and&#xD;
      improve respiratory health.&#xD;
&#xD;
      In this project, the investigators propose to test the efficacy of an education-based&#xD;
      intervention strategy for reducing indoor wood smoke exposures and children's risk of LRTI in&#xD;
      three unique and underserved settings. This study is a three-arm randomized trial in wood&#xD;
      stove homes with children less than five years old. Education on best-burn practices and&#xD;
      training on the use of simple instruments (i.e., stove thermometers and wood moisture meters)&#xD;
      will be introduced as one intervention arm (Tx1). This intervention will be evaluated against&#xD;
      an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters).&#xD;
      The primary outcome will be LRTI incidence among children under five years of age. A sample&#xD;
      of 324 homes, or 108 within each study area equally assigned to each of the three&#xD;
      intervention arms, will allow for detection of exposure and outcome differences within each&#xD;
      of the three regions. Through three Aims, the overall hypothesis is that a low-cost,&#xD;
      educational intervention targeting indoor wood smoke (PM2.5) exposures will be an effective,&#xD;
      sustainable strategy for reducing children's risk of LRTI in underserved Native and rural&#xD;
      communities.&#xD;
&#xD;
      Aim 1: Compare LRTI incidence in each intervention arm (Tx1 and Tx2) to LRTI in the placebo&#xD;
      arm (Tx3). Investigators hypothesize that children less than five years old in intervention&#xD;
      homes will experience lower LRTI.&#xD;
&#xD;
      Aim 2: Compare indoor PM2.5 concentrations in each treatment arm relative to the placebo arm.&#xD;
      Investigators hypothesize that the intervention homes will have lower indoor PM2.5&#xD;
      concentrations.&#xD;
&#xD;
      Aim 3: Compare effectiveness and sustainability of treatment strategies relative to placebo,&#xD;
      both within and between regional sites. Investigators hypothesize that Tx1 will be more&#xD;
      effective and sustainable than Tx2.&#xD;
&#xD;
      Impact. LRTI is an important cause of morbidity among children, and exposure to biomass smoke&#xD;
      puts children at a greater risk of LRTI. By reducing in-home wood smoke exposures, this study&#xD;
      will evaluate sustainable evidence-based and culturally appropriate strategies for decreasing&#xD;
      occurrence of LRTI. In addition, comparing the effectiveness of these interventions across&#xD;
      three unique rural and Native regions will inform translation of study findings into diverse&#xD;
      settings that utilize biomass fuels for heating and cooking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With at Least One LRTI During Follow-up Period</measure>
    <time_frame>The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.</time_frame>
    <description>The occurrence and duration of LRTI among children will be assessed using active surveillance within the home. Identification of LRTI episodes will occur through a three step process: (1) parent reporting of symptoms; (2) Community Coordinator collection of confirmatory and severity data; and (3) physician classification of case status based on data collected by the Community Coordinator, and when available, data collected from a clinic or hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fine Particulate Matter Concentrations</measure>
    <time_frame>Six consecutive days during a four month winter period</time_frame>
    <description>Fine particulate matter (PM2.5) concentrations by study arm</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">523</enrollment>
  <condition>Lower Tract Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Education Intervention (Tx1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air Filtration Unit Treatment (Tx2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Within each randomly assigned home, a 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Intervention (Tx3)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education Intervention (Tx1)</intervention_name>
    <description>The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
    <arm_group_label>Education Intervention (Tx1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air Filtration Unit Treatment (Tx2)</intervention_name>
    <description>A 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the &quot;high&quot; setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.</description>
    <arm_group_label>Air Filtration Unit Treatment (Tx2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Intervention (Tx3)</intervention_name>
    <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
    <arm_group_label>Placebo Intervention (Tx3)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible homes will be any home in the described communities that uses a wood stove as&#xD;
             a primary heating source, and has one or more children under the age of five years.&#xD;
             The home must include a parent who is capable and willing to record symptom data for&#xD;
             the enrolled children and wood stove usage data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Curtis W Noonan, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Montana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tony J Ward, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Montana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Montana</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>March 18, 2022</results_first_submitted>
  <results_first_submitted_qc>May 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2022</results_first_posted>
  <last_update_submitted>June 1, 2022</last_update_submitted>
  <last_update_submitted_qc>June 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Montana</investigator_affiliation>
    <investigator_full_name>Curtis Noonan</investigator_full_name>
    <investigator_title>Principal Investigator, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 11, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02240134/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The KidsAIR study took place in rural areas of Alaska (AK), Navajo Nation (NN), and western Montana (WMT) where wood stoves are a common source of heating during the colder winter months. Contact with potentially eligible households occurred through clinics and advertisements. Households were enrolled from 2014 through 2018.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Education Intervention (Tx1)</title>
          <description>The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.&#xD;
Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
        </group>
        <group group_id="P2">
          <title>Air Filtration Unit Treatment (Tx2)</title>
          <description>Within each randomly assigned home, a 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the &quot;high&quot; setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.</description>
        </group>
        <group group_id="P3">
          <title>Placebo Intervention (Tx3)</title>
          <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="176"/>
                <participants group_id="P3" count="171"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="123"/>
                <participants group_id="P3" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Education Intervention (Tx1)</title>
          <description>The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.&#xD;
Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
        </group>
        <group group_id="B2">
          <title>Air Filtration Unit Treatment (Tx2)</title>
          <description>Within each randomly assigned home, a 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the &quot;high&quot; setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.</description>
        </group>
        <group group_id="B3">
          <title>Placebo Intervention (Tx3)</title>
          <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="176"/>
            <count group_id="B2" value="176"/>
            <count group_id="B3" value="171"/>
            <count group_id="B4" value="523"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 1 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 - 4 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="113"/>
                    <measurement group_id="B4" value="344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="80"/>
                    <measurement group_id="B4" value="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="149"/>
                    <measurement group_id="B4" value="441"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="192"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="232"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="176"/>
                    <measurement group_id="B3" value="171"/>
                    <measurement group_id="B4" value="523"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Received influenza vaccine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="240"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least One LRTI During Follow-up Period</title>
        <description>The occurrence and duration of LRTI among children will be assessed using active surveillance within the home. Identification of LRTI episodes will occur through a three step process: (1) parent reporting of symptoms; (2) Community Coordinator collection of confirmatory and severity data; and (3) physician classification of case status based on data collected by the Community Coordinator, and when available, data collected from a clinic or hospital.</description>
        <time_frame>The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.</time_frame>
        <population>Children were evaluated during two consecutive winters for occurrence of lower respiratory tract infection (LRTI). Below are number of children with at least one LRTI during follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention (Tx1)</title>
            <description>The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.&#xD;
Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>Within each randomly assigned home, a 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the &quot;high&quot; setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One LRTI During Follow-up Period</title>
          <description>The occurrence and duration of LRTI among children will be assessed using active surveillance within the home. Identification of LRTI episodes will occur through a three step process: (1) parent reporting of symptoms; (2) Community Coordinator collection of confirmatory and severity data; and (3) physician classification of case status based on data collected by the Community Coordinator, and when available, data collected from a clinic or hospital.</description>
          <population>Children were evaluated during two consecutive winters for occurrence of lower respiratory tract infection (LRTI). Below are number of children with at least one LRTI during follow-up period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Recorded LRTI</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No recorded LRTI</title>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="136"/>
                    <measurement group_id="O3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>3.32</ci_upper_limit>
            <estimate_desc>Odds ratio for air filter treatment relative to placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.96</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>2.72</ci_upper_limit>
            <estimate_desc>Odds ratio for filter treatment relative to placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fine Particulate Matter Concentrations</title>
        <description>Fine particulate matter (PM2.5) concentrations by study arm</description>
        <time_frame>Six consecutive days during a four month winter period</time_frame>
        <population>Assessment made at the household level</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention (Tx1)</title>
            <description>The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.&#xD;
Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
          </group>
          <group group_id="O2">
            <title>Air Filtration Unit Treatment (Tx2)</title>
            <description>Within each randomly assigned home, a 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the &quot;high&quot; setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.</description>
          </group>
          <group group_id="O3">
            <title>Placebo Intervention (Tx3)</title>
            <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
          </group>
        </group_list>
        <measure>
          <title>Fine Particulate Matter Concentrations</title>
          <description>Fine particulate matter (PM2.5) concentrations by study arm</description>
          <population>Assessment made at the household level</population>
          <units>Microgram/cubic meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Household</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="151"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Household</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="84"/>
                <count group_id="O3" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" spread="45"/>
                    <measurement group_id="O2" value="30" spread="37"/>
                    <measurement group_id="O3" value="32" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.250</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>percent differences in geometric mean PM</param_type>
            <param_value>-6.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.50</ci_lower_limit>
            <ci_upper_limit>24.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.295</p_value>
            <p_value_desc>Statistical significance selected as 95% confidence interval of the estimation parameter that excludes the null value, 0.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>percent differences in geometric mean PM</param_type>
            <param_value>11.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.57</ci_lower_limit>
            <ci_upper_limit>49.72</ci_upper_limit>
            <estimate_desc>Difference in indoor PM2.5 for education treatment versus placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Education Intervention (Tx1)</title>
          <description>The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.&#xD;
Education Intervention (Tx1): The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.</description>
        </group>
        <group group_id="E2">
          <title>Air Filtration Unit Treatment (Tx2)</title>
          <description>Within each randomly assigned home, a 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.&#xD;
Air Filtration Unit Treatment (Tx2): A 20&quot; x 18&quot; Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the &quot;high&quot; setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.</description>
        </group>
        <group group_id="E3">
          <title>Placebo Intervention (Tx3)</title>
          <description>Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.&#xD;
Placebo Intervention (Tx3): Similar to Tx1, a 20&quot; x 18&quot; Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="171"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Curtis Noonan, PhD</name_or_title>
      <organization>University of Montana</organization>
      <phone>406-243-4957</phone>
      <email>curtis.noonan@umontana.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02240134
org study id: IRB 276-13
secondary id: R01ES022649
nct id: NCT02240134
lead sponsor: 
collaborator: 
has dmc: No
Acute lower respiratory tract infections (LRTIs) account for more than 27% of all
      hospitalizations among US children under five years of age, with recurrent LRTIs in children
      a recognized risk factor for asthma. Residential biomass combustion leads to elevated indoor
      levels of fine particulate matter (PM2.5) that often exceed current health-based air quality
      standards. PM2.5 exposure is associated with many adverse health outcomes, including a
      greater than three-fold increased risk of LRTIs. To date, exposure reduction strategies in
      wood stove homes have been either inconsistently effective or include factors that limit
      widespread dissemination and continued compliance in rural and economically disadvantaged
      populations. In this project, the investigators propose to test the efficacy of two
      intervention strategies for reducing indoor wood smoke PM2.5 exposures and children's risk of
      LRTI in three unique and underserved settings: (1) rural mountain valley communities in
      western Montana; (2) Navajo Nation communities; and (3) Alaska Native Villages. The
      investigators will conduct a three-arm randomized placebo-controlled post-only intervention
      trial in wood stove homes with children less than five years old. Education on best-burn
      practices and training on the use of simple instruments (i.e., stove thermometers and wood
      moisture meters) will be introduced as one intervention arm (Tx1). This intervention will be
      evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3,
      sham air filters). The primary outcome will be LRTI incidence among children under five years
      of age. To allow for detection of exposure and outcome differences within each of the three
      regions, a sample of 324 homes, or 108 within each study area will be equally assigned to
      each of the three intervention arms. The overall hypothesis is that a low-cost, educational
      intervention targeting indoor wood smoke PM2.5 exposures will be sustainable, and can reduce
      children's risk of LRTI in underserved Native and rural communities.
Rural and Native areas of the western United States (US) and Alaska experience substantial
      exposure and health disparities compared to more populated urban centers. One such source of
      disparity is the elevated inhalation exposures related to the use of wood stoves for home
      heating. Within rural areas of Montana, Alaska, and the Navajo Nation, research has shown
      that residential biomass combustion leads to indoor levels of fine particulate matter (PM2.5)
      that often exceed current health-based air quality standards. Parallel findings have been
      observed in several developing countries where biomass combustion is commonly used for
      cooking and/or heating. This is concerning, as PM2.5 exposure is associated with many adverse
      health outcomes, including a greater than three-fold increased risk of acute respiratory
      tract infections. Throughout the world, lower respiratory tract infections (LRTIs) are the
      most common cause of death in children under five years of age, and account for more than 27%
      of all hospitalizations among US children under five years. Importantly, untoward effects of
      recurrent LRTIs are cumulative in children and a recognized risk factor for asthma.

      Currently, there is a global effort to reduce indoor biomass smoke exposures in developing
      countries. A recent intervention trial found that exposure reductions following the
      introduction of improved cookstoves was protective for severe infant pneumonia. Similar
      evidence-based efforts are warranted in rural and Native American communities in the US that
      suffer from elevated rates of childhood LRTI and commonly use wood for residential heating.
      The investigators have previously demonstrated that a community-wide wood stove changeout
      program (i.e., replacing old wood stoves with newer model wood stoves) resulted in reduced
      wintertime ambient PM2.5 and corresponding reductions in occurrence of childhood wheeze and
      respiratory infections. In this and other studies, however, inconsistent effects on indoor
      air quality following the introduction of newer technology wood stoves have been observed.
      The investigators have also shown that the introduction of air filtration units is a less
      costly and more efficacious strategy for reducing indoor wood smoke exposures. Nevertheless,
      the energy costs of operation and need for filter replacement (maintenance) remain barriers
      to widespread dissemination and continued compliance in rural and economically disadvantaged
      communities. Experience with these interventions and qualitative input from wood stove
      experts suggest that educational interventions related to wood stove operation can translate
      to low-cost and sustainable strategies that reduce indoor biomass combustion exposures and
      improve respiratory health.

      In this project, the investigators propose to test the efficacy of an education-based
      intervention strategy for reducing indoor wood smoke exposures and children's risk of LRTI in
      three unique and underserved settings. This study is a three-arm randomized trial in wood
      stove homes with children less than five years old. Education on best-burn practices and
      training on the use of simple instruments (i.e., stove thermometers and wood moisture meters)
      will be introduced as one intervention arm (Tx1). This intervention will be evaluated against
      an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters).
      The primary outcome will be LRTI incidence among children under five years of age. A sample
      of 324 homes, or 108 within each study area equally assigned to each of the three
      intervention arms, will allow for detection of exposure and outcome differences within each
      of the three regions. Through three Aims, the overall hypothesis is that a low-cost,
      educational intervention targeting indoor wood smoke (PM2.5) exposures will be an effective,
      sustainable strategy for reducing children's risk of LRTI in underserved Native and rural
      communities.

      Aim 1: Compare LRTI incidence in each intervention arm (Tx1 and Tx2) to LRTI in the placebo
      arm (Tx3). Investigators hypothesize that children less than five years old in intervention
      homes will experience lower LRTI.

      Aim 2: Compare indoor PM2.5 concentrations in each treatment arm relative to the placebo arm.
      Investigators hypothesize that the intervention homes will have lower indoor PM2.5
      concentrations.

      Aim 3: Compare effectiveness and sustainability of treatment strategies relative to placebo,
      both within and between regional sites. Investigators hypothesize that Tx1 will be more
      effective and sustainable than Tx2.

      Impact. LRTI is an important cause of morbidity among children, and exposure to biomass smoke
      puts children at a greater risk of LRTI. By reducing in-home wood smoke exposures, this study
      will evaluate sustainable evidence-based and culturally appropriate strategies for decreasing
      occurrence of LRTI. In addition, comparing the effectiveness of these interventions across
      three unique rural and Native regions will inform translation of study findings into diverse
      settings that utilize biomass fuels for heating and cooking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of Participants With at Least One LRTI During Follow-up Period
time frame: The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.
description: The occurrence and duration of LRTI among children will be assessed using active surveillance within the home. Identification of LRTI episodes will occur through a three step process: (1) parent reporting of symptoms; (2) Community Coordinator collection of confirmatory and severity data; and (3) physician classification of case status based on data collected by the Community Coordinator, and when available, data collected from a clinic or hospital.
measure: Fine Particulate Matter Concentrations
time frame: Six consecutive days during a four month winter period
description: Fine particulate matter (PM2.5) concentrations by study arm
arm group label: Education Intervention (Tx1)
arm group type: Experimental
description: The education components for this intervention are based on recent observations and recommendations from tribal, local, state and federal agencies. The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.
arm group label: Air Filtration Unit Treatment (Tx2)
arm group type: Active Comparator
description: Within each randomly assigned home, a 20" x 18" Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove.
arm group label: Placebo Intervention (Tx3)
arm group type: Sham Comparator
description: Similar to Tx1, a 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
intervention type: Behavioral
intervention name: Education Intervention (Tx1)
description: The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.
arm group label: Education Intervention (Tx1)
intervention type: Device
intervention name: Air Filtration Unit Treatment (Tx2)
description: A 20" x 18" Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the "high" setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency.
arm group label: Air Filtration Unit Treatment (Tx2)
intervention type: Device
intervention name: Placebo Intervention (Tx3)
description: Similar to Tx1, a 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
arm group label: Placebo Intervention (Tx3)
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Curtis W Noonan, Ph.D.
role: Principal Investigator
affiliation: University of Montana
last name: Tony J Ward, Ph.D.
role: Principal Investigator
affiliation: University of Montana
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Montana
investigator full name: Curtis Noonan
investigator title: Principal Investigator, Professor
mesh term: Infections
mesh term: Respiratory Tract Infections
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 