The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa

Study Overview
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Brief Summary
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This study will evaluate the feasibility and acceptability of a household-based clean air intervention

Detailed Description
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A clean air intervention will be implemented in each household, including HEPA- based air filtration, solar lighting, and education. The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off. To determine the effect of the clean air intervention within the household, PM2.5 concentration during each cycle and lung function will be measured among household members.

Official Title
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The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa

Conditions
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Pneumonia, Pollution; Exposure, Lung Function Decreased, Chronic Respiratory Disease, Pediatric Respiratory Diseases, Lungs; Developmental Disorder

Intervention / Treatment
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* Other: Clean Air Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 12 months • First episode of WHO-defined severe pneumonia22: cough or difficulty breathing with Oxygen saturation < 90% or central cyanosis, Severe respiratory distress, or Signs of pneumonia with a general danger sign Be willing to commit to entire 2 years of follow up visits. (Controls) Matched to each case on age (+/-1 month), sex, and community Exclusion Criteria: Craniofacial, cardiac or other major malformation Neuromuscular condition that affects respiration Outside Smart Discharges Project catchment area Prior hospitalizations or known episodes of respiratory illness or episodes of pneumonia before index admission,

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clean air intervention<br>See detailed description | Other: Clean Air Intervention<br>* Based on findings from preliminary focus groups/in-depth interviews, staff will introduce various components of established clean air interventions to each household. Each household will receive interventions, depending on their known risk factors, exposures, and willingness to trial the intervention. Study staff will ask the primary cook to complete a time-activity diary during the intervention period that includes cooking episodes, duration of cooking, stove(s) used, type of food cooked, and number of people for whom the meal was cooked. Staff will continuously monitor use of the LPG/pellet stove and any other stoves owned by the household with the Berkeley Stove Use Monitoring System, a temperature logger attached to the stove to quantify the number of stove uses / time of use . Study staff will use similar loggers to monitor use of other devices installed including the air purifiers, lighting etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of the clean intervention | Adherence with the intervention (% total up-time of the air purifier) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air quality | PM2.5 concentration | Up to 2 years | 
| Pulmonary function testing | Pulmonary function testing will be performed in household members | Up to 2 years | 
| Acceptability of using air filter device | Acceptability will be assessed using structured interviews with participating households. | Up to 2 years |