Trial Outcomes & Findings for Wood Stove Interventions and Child Respiratory Health (NCT NCT02240134)
NCT ID: NCT02240134
Last Updated: 2022-06-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
523 participants
Primary outcome timeframe
The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation.
Results posted on
2022-06-22
Participant Flow
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.
Unit of analysis: Household
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
176 118
|
176 115
|
171 114
|
|
Overall Study
COMPLETED
|
126 81
|
123 79
|
118 78
|
|
Overall Study
NOT COMPLETED
|
50 37
|
53 36
|
53 36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wood Stove Interventions and Child Respiratory Health
Baseline characteristics by cohort
| Measure |
Education Intervention (Tx1)
n=176 Participants
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.
|
Air Filtration Unit Treatment (Tx2)
n=176 Participants
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.
|
Placebo Intervention (Tx3)
n=171 Participants
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.
|
Total
n=523 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 1 year
|
38 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
116 Participants
n=483 Participants
|
|
Age, Customized
1 - 4 years
|
115 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
344 Participants
n=483 Participants
|
|
Age, Customized
Unknown
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Female
|
70 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
199 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
76 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
237 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Unknown
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
87 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
441 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
68 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
192 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
232 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
67 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
176 participants
n=93 Participants
|
176 participants
n=4 Participants
|
171 participants
n=27 Participants
|
523 participants
n=483 Participants
|
|
Received influenza vaccine
Yes
|
64 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
193 Participants
n=483 Participants
|
|
Received influenza vaccine
No
|
81 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
240 Participants
n=483 Participants
|
|
Received influenza vaccine
Unknown
|
31 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Education Intervention (Tx1)
n=154 Participants
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.
|
Air Filtration Unit Treatment (Tx2)
n=156 Participants
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.
|
Placebo Intervention (Tx3)
n=151 Participants
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.
|
|---|---|---|---|
|
Number of Participants With at Least One LRTI During Follow-up Period
Recorded LRTI
|
16 Participants
|
20 Participants
|
17 Participants
|
|
Number of Participants With at Least One LRTI During Follow-up Period
No recorded LRTI
|
138 Participants
|
136 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: Six consecutive days during a four month winter periodPopulation: Assessment made at the household level
Fine particulate matter (PM2.5) concentrations by study arm
Outcome measures
| Measure |
Education Intervention (Tx1)
n=84 Household
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.
|
Air Filtration Unit Treatment (Tx2)
n=84 Household
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.
|
Placebo Intervention (Tx3)
n=85 Household
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.
|
|---|---|---|---|
|
Fine Particulate Matter Concentrations
|
36 Microgram/cubic meter
Standard Deviation 45
|
30 Microgram/cubic meter
Standard Deviation 37
|
32 Microgram/cubic meter
Standard Deviation 36
|
Adverse Events
Education Intervention (Tx1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Air Filtration Unit Treatment (Tx2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Intervention (Tx3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place