Skip to content

Wood Stove Interventions and Child Respiratory Health

Wood Stove Interventions and Child Respiratory Infections in Rural Communities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02240134
Acronym
KidsAIR
Enrollment
523
Registered
2014-09-15
Start date
2014-11-30
Completion date
2020-03-31
Last updated
2022-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Tract Respiratory Infection

Brief 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. 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.

Interventions

BEHAVIORALEducation 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.

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.

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.

Sponsors

National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH
University of Montana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With at Least One LRTI During Follow-up PeriodThe 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.

Secondary

MeasureTime frameDescription
Fine Particulate Matter ConcentrationsSix consecutive days during a four month winter periodFine particulate matter (PM2.5) concentrations by study arm

Countries

United States

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.

Participants by arm

ArmCount
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. 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.
176
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. 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.
176
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. 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.
171
Total523

Baseline characteristics

CharacteristicEducation Intervention (Tx1)Air Filtration Unit Treatment (Tx2)Placebo Intervention (Tx3)Total
Age, Customized
1 - 4 years
115 Participants116 Participants113 Participants344 Participants
Age, Customized
< 1 year
38 Participants40 Participants38 Participants116 Participants
Age, Customized
Unknown
24 Participants20 Participants20 Participants64 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants7 Participants2 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
146 Participants146 Participants149 Participants441 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
25 Participants23 Participants20 Participants68 Participants
Race (NIH/OMB)
American Indian or Alaska Native
68 Participants63 Participants61 Participants192 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
11 Participants12 Participants9 Participants32 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
25 Participants22 Participants20 Participants67 Participants
Race (NIH/OMB)
White
72 Participants79 Participants81 Participants232 Participants
Received influenza vaccine
No
81 Participants83 Participants76 Participants240 Participants
Received influenza vaccine
Unknown
31 Participants32 Participants27 Participants90 Participants
Received influenza vaccine
Yes
64 Participants61 Participants68 Participants193 Participants
Region of Enrollment
United States
176 participants176 participants171 participants523 participants
Sex/Gender, Customized
Female
70 Participants65 Participants64 Participants199 Participants
Sex/Gender, Customized
Male
76 Participants81 Participants80 Participants237 Participants
Sex/Gender, Customized
Unknown
30 Participants30 Participants27 Participants87 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1760 / 1760 / 171
other
Total, other adverse events
0 / 1760 / 1760 / 171
serious
Total, serious adverse events
0 / 1760 / 1760 / 171

Outcome results

Primary

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.

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.

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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Education Intervention (Tx1)Number of Participants With at Least One LRTI During Follow-up PeriodRecorded LRTI16 Participants
Education Intervention (Tx1)Number of Participants With at Least One LRTI During Follow-up PeriodNo recorded LRTI138 Participants
Air Filtration Unit Treatment (Tx2)Number of Participants With at Least One LRTI During Follow-up PeriodRecorded LRTI20 Participants
Air Filtration Unit Treatment (Tx2)Number of Participants With at Least One LRTI During Follow-up PeriodNo recorded LRTI136 Participants
Placebo Intervention (Tx3)Number of Participants With at Least One LRTI During Follow-up PeriodRecorded LRTI17 Participants
Placebo Intervention (Tx3)Number of Participants With at Least One LRTI During Follow-up PeriodNo recorded LRTI134 Participants
Comparison: 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.p-value: 0.6895% CI: [0.46, 3.32]Mixed Models Analysis
Comparison: 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.p-value: 0.9695% CI: [0.35, 2.72]Mixed Models Analysis
Secondary

Fine Particulate Matter Concentrations

Fine particulate matter (PM2.5) concentrations by study arm

Time frame: Six consecutive days during a four month winter period

Population: Assessment made at the household level

ArmMeasureValue (MEAN)Dispersion
Education Intervention (Tx1)Fine Particulate Matter Concentrations36 Microgram/cubic meterStandard Deviation 45
Air Filtration Unit Treatment (Tx2)Fine Particulate Matter Concentrations30 Microgram/cubic meterStandard Deviation 37
Placebo Intervention (Tx3)Fine Particulate Matter Concentrations32 Microgram/cubic meterStandard Deviation 36
Comparison: 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.p-value: 0.2595% CI: [-30.5, 24.55]Mixed Models Analysis
Comparison: 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.p-value: 0.29595% CI: [-16.57, 49.72]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026