Lower Tract Respiratory InfectionKidsAIRNCT02240134
Wood Stove Interventions and Child Respiratory Health
A study testing Education Intervention (Tx1) and Air Filtration Unit Treatment (Tx2) in people with Lower Tract Respiratory Infection, run by University of Montana at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Tract Respiratory Infection
- What is being tested?
- Education Intervention (Tx1) and Air Filtration Unit Treatment (Tx2)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 523 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Eligible homes will be any home in the described communities that uses a wood stove as a primary heating source, and has one or more children under the age of five years. The home must include a parent who is capable and willing to record symptom data for the enrolled children and wood stove usage data.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wood Stove Interventions and Child Respiratory Infections in Rural Communities
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.
Read the detailed description
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.
- Conditions
- Lower Tract Respiratory Infection
- Being tested
- Education Intervention (Tx1), Air Filtration Unit Treatment (Tx2), Placebo Intervention (Tx3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Intervention (Tx1)Behavioural
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.
Air Filtration Unit Treatment (Tx2)Device
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.
Placebo Intervention (Tx3)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Education Intervention (Tx1) | Experimental | 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. Receives: Behavioral: Education Intervention (Tx1) |
| Air Filtration Unit Treatment (Tx2) | Active comparator | 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. Receives: Device: Air Filtration Unit Treatment (Tx2) |
| Placebo Intervention (Tx3) | Sham comparator | 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. Receives: Device: Placebo Intervention (Tx3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One LRTI During Follow-up Period
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.
Measured: The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.
Secondary outcomes (1)
Fine Particulate Matter Concentrations
Fine particulate matter (PM2.5) concentrations by study arm
Measured: Six consecutive days during a four month winter period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Tract Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Curtis Noonan, University of Montana
- Investigators
- Curtis W Noonan, Ph.D., Principal investigator, University of MontanaTony J Ward, Ph.D., Principal investigator, University of Montana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240134
- Sponsor's protocol ID
- IRB 276-13
- Other IDs
- R01ES022649
- Acronym
- KidsAIR
- Status last verified
- Jun 2022
- First submitted
- 10 Sep 2014
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wood Stove Interventions and Child Respiratory Infections in Rural Communities
- ClinicalTrials.gov ID
- NCT02240134
- Acronym / sponsor ID
- KidsAIR / IRB 276-13
- Conditions
- Lower Tract Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education Intervention (Tx1) | Experimental | Behavioral: Education Intervention (Tx1)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. |
| Air Filtration Unit Treatment (Tx2) | Active comparator | Device: Air Filtration Unit Treatment (Tx2)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. |
| Placebo Intervention (Tx3) | Sham comparator | Device: Placebo Intervention (Tx3)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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Eligible homes will be any home in the described communities that uses a wood stove as a primary heating source, and has one or more children under the age of five years. The home must include a parent who is capable and willing to record symptom data for the enrolled children and wood stove usage data.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Education Intervention (Tx1) |
| Air Filtration Unit Treatment (Tx2)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. | Device | Air Filtration Unit Treatment (Tx2) |
| Placebo Intervention (Tx3)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. | Device | Placebo Intervention (Tx3) |
Primary outcome
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.
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.
1 secondary outcome
Fine Particulate Matter Concentrations
Time frame: Six consecutive days during a four month winter period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis W Noonan, Ph.D. principal investigator
University of Montana
Tony J Ward, Ph.D. principal investigator
University of Montana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention (Tx1) and Air Filtration Unit Treatment (Tx2) in people with Lower Tract Respiratory Infection, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.