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

Not Applicable

• Conditions: Pneumonia; Pollution; Exposure; Pediatric Respiratory Diseases; Chronic Respiratory Disease; Lungs; Developmental Disorder; Lung Function Decreased
• Interventions: Other: Clean Air Intervention

• Registration Number: NCT05724082
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-13
• Study Start: 2023-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Clean air intervention	Clean Air Intervention	See detailed description

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of the clean intervention	2 years	Adherence with the intervention (% total up-time of the air purifier)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mbarara University of Science and Technology; 🇺🇬 Mbarara, Uganda