search
Back to results

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

Primary Purpose

Pneumonia, Pollution; Exposure, Lung Function Decreased

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Clean Air Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia

Eligibility Criteria

1 Month - 11 Months (Child)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clean air intervention

Arm Description

See detailed description

Outcomes

Primary Outcome Measures

Feasibility and acceptability of the clean intervention
Adherence with the intervention (% total up-time of the air purifier)

Secondary Outcome Measures

Air quality
PM2.5 concentration
Pulmonary function testing
Pulmonary function testing will be performed in household members
Acceptability of using air filter device
Acceptability will be assessed using structured interviews with participating households.

Full Information

First Posted
February 1, 2022
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT05724082
Brief Title
The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
Acronym
PLUS2
Official Title
The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pollution; Exposure, Lung Function Decreased, Chronic Respiratory Disease, Pediatric Respiratory Diseases, Lungs; Developmental Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clean air intervention
Arm Type
Experimental
Arm Description
See detailed description
Intervention Type
Other
Intervention Name(s)
Clean Air Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of the clean intervention
Description
Adherence with the intervention (% total up-time of the air purifier)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Air quality
Description
PM2.5 concentration
Time Frame
Up to 2 years
Title
Pulmonary function testing
Description
Pulmonary function testing will be performed in household members
Time Frame
Up to 2 years
Title
Acceptability of using air filter device
Description
Acceptability will be assessed using structured interviews with participating households.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Moschovis, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerome Kabakyenga, MBChB, MPH, PhD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs