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NCT05724082 Clinical Trial

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

Pneumonia Clinical Trial

— PLUS2  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05724082
Other study ID # 2019P000649
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date April 30, 2025

Study information
Verified date October 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 25
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 11 Months
Eligibility 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,

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Clean 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.

Locations
Country Name City State
Uganda Mbarara University of Science and Technology Mbarara

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility and acceptability of the clean intervention Adherence with the intervention (% total up-time of the air purifier) 2 years
Secondary Air quality PM2.5 concentration Up to 2 years
Secondary Pulmonary function testing Pulmonary function testing will be performed in household members Up to 2 years
Secondary Acceptability of using air filter device Acceptability will be assessed using structured interviews with participating households. Up to 2 years
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