Wood Stove Interventions and Child Respiratory Health

NCT02240134 | Completed Results

• 2 other identifiers: IRB 276-13R01ES022649
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Tract Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fine Particulate Matter Concentrations

  Six consecutive days during a four month winter period

Study Arms (3)

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.

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.

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.

Device: Placebo Intervention (Tx3)

Interventions

Education Intervention (Tx1) BEHAVIORAL

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)

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.

Air Filtration Unit Treatment (Tx2)

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.

Placebo Intervention (Tx3)

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• University of Montana: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

Location

Results Point of Contact

• Title: Curtis Noonan, PhD
• Organization: University of Montana

curtis.noonan@umontana.edu

406-243-4957

Study Officials

• Curtis W Noonan, Ph.D.

  University of Montana

  PRINCIPAL INVESTIGATOR

• Tony J Ward, Ph.D.

  University of Montana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 15, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 22, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-06

Locations

US (1)