The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa (PLUS2)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pneumonia; Pollution; Exposure; Pediatric Respiratory Diseases; Lung Function Decreased; Chronic Respiratory Disease; Lungs; Developmental Disorder
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda
    • Mbarara University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 11 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Clean air intervention; See detailed description

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Mbarara University of Science and Technology
• Investigators: Principal Investigator: Peter Moschovis, MD, Massachusetts General Hospital; Principal Investigator: Jerome Kabakyenga, MBChB, MPH, PhD, Mbarara University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Infections; Respiratory Tract Infections; Lung Diseases; Neurodevelopmental Disorders; Pneumonia; Developmental Disabilities; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2019P000649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No