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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05724082
Acronym
PLUS2
Enrollment
25
Registered
2023-02-13
Start date
2023-05-01
Completion date
2025-04-30
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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.

Interventions

OTHERClean Air Intervention

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.

Sponsors

Mbarara University of Science and Technology
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.

Eligibility

Sex/Gender
ALL
Age
1 Months to 11 Months
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability of the clean intervention2 yearsAdherence with the intervention (% total up-time of the air purifier)

Secondary

MeasureTime frameDescription
Air qualityUp to 2 yearsPM2.5 concentration
Pulmonary function testingUp to 2 yearsPulmonary function testing will be performed in household members
Acceptability of using air filter deviceUp to 2 yearsAcceptability will be assessed using structured interviews with participating households.

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026