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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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,

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Developmental Disabilities
• Lung Function Decreased
• Pediatric Respiratory Diseases
• Pneumonia
• Pollution; Exposure
• Respiration Disorders
• Respiratory Tract Diseases

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