Wood Stove Interventions and Child Respiratory Health

Lower Tract Respiratory Infection Clinical Trial

— KidsAIR  

Official title:

Wood Stove Interventions and Child Respiratory Infections in Rural Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240134
• Other study ID #: IRB 276-13
• Secondary ID: R01ES022649
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 2020

Study information

• Verified date: June 2022
• Source: University of Montana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Lower Tract Respiratory Infection
• Respiratory Tract Infections

Intervention

Behavioral:
• 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.

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Montana	Missoula	Montana

Sponsors (2)

Lead Sponsor	Collaborator
University of Montana	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.
Secondary	Fine Particulate Matter Concentrations	Fine particulate matter (PM2.5) concentrations by study arm	Six consecutive days during a four month winter period