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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05724082
Collaborator
Mbarara University of Science and Technology (Other)
25
1
11

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.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)
Primary Purpose:
Prevention
Official Title:
The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility and acceptability of the clean intervention [2 years]

    Adherence with the intervention (% total up-time of the air purifier)

Secondary Outcome Measures

  1. Air quality [Up to 2 years]

    PM2.5 concentration

  2. Pulmonary function testing [Up to 2 years]

    Pulmonary function testing will be performed in household members

  3. Acceptability of using air filter device [Up to 2 years]

    Acceptability will be assessed using structured interviews with participating households.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 11 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Massachusetts General Hospital
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Moschovis, Principal Investigator, Pediatric Pulmonologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05724082
Other Study ID Numbers:
  • 2019P000649
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023