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

NCT05724082 — Not applicable, Unknown, 25 participants, Massachusetts General Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT05724082, acronym PLUS2
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, sequential, masking: none, prevention
Enrollment25 (Estimated)
SponsorMassachusetts General Hospital (Other); collaborators: Mbarara University of Science and Technology
ConditionsPneumonia, Pollution; Exposure, Lung Function Decreased, Chronic Respiratory Disease, Pediatric Respiratory Diseases, Lungs; Developmental Disorder
InterventionsClean Air Intervention (Other)
Datesstart 2023-05-01, primary completion 2025-04-30 (estimated), completion 2025-04-30 (estimated), first posted 2023-02-13, last updated 2023-10-18
Locations1 site in Uganda

Related Papers Related Patents Related Grants Related Experts
All trials for Pneumonia All trials for Pollution; Exposure All trials of Clean Air Intervention

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Clean air interventionExperimentalOther: Clean Air InterventionSee detailed description
  • Clean Air Intervention (Other): 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 outcomes

  • Feasibility and acceptability of the clean intervention [2 years]: Adherence with the intervention (% total up-time of the air purifier)

Secondary outcomes

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

+Eligibility

Sex: All, ages: 1 Month to 11 Months, accepts 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,

+Locations (1)

FacilityCityCountryStatus
Mbarara University of Science and TechnologyMbararaUganda

+Investigators