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NCT02240134 · ClinicalTrials.gov registry record · NA
Wood Stove Interventions and Child Respiratory Health
A NA study of Lower Tract Respiratory Infection, sponsored by University of Montana.
- Completed
- Registry status
- NA
- Development phase
- 523
- Enrollment target
- 1
- Study location
NCT02240134 is a NA study of Lower Tract Respiratory Infection that has completed, run by University of Montana. The registered enrollment target is 523 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02240134, a NA study of Lower Tract Respiratory Infection, has completed, sponsored by University of Montana.
- COMPLETED
- Registry status
- NA
- Development phase
- 523 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Education Intervention (Tx1)
- DEVICE Air Filtration Unit Treatment (Tx2)
- DEVICE Placebo Intervention (Tx3)
Study Locations (1)
Montana
- University of Montana - Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 523 participants |
| Start Date | 2014-11 |
| Est. Completion | 2020-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02240134
The ClinicalTrials.gov registry entry for NCT02240134 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 523 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Montana, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lower Tract Respiratory Infection appearing as the primary indexed condition, and to 3 interventions - of which Education Intervention (Tx1) is the first listed.
NCT02240134 reports 1 study location spanning 1 distinct geographic area - top geographies include Montana.
Frequently Asked Questions
What is clinical trial NCT02240134 about?
NCT02240134 is a clinical study titled "Wood Stove Interventions and Child Respiratory Health". 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 matte...
What is the current status of trial NCT02240134?
This trial is currently completed. It is a NA study. The enrollment target is 523 participants. The study started on 2014-11. Estimated completion is 2020-03.
What conditions does trial NCT02240134 study?
This clinical trial studies the following conditions: Lower Tract Respiratory Infection.
What interventions are being tested in trial NCT02240134?
The interventions under investigation include: Education Intervention (Tx1) (BEHAVIORAL), Air Filtration Unit Treatment (Tx2) (DEVICE), Placebo Intervention (Tx3) (DEVICE).
Who is sponsoring clinical trial NCT02240134?
This trial is sponsored by University of Montana, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02240134 being conducted?
This trial has 1 study location across Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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