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

NCT05724082 | Unknown DMC

• 1 other identifier: 2019P000649
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia; Pollution; Exposure; Lung Function Decreased; Chronic Respiratory Disease; Pediatric Respiratory Diseases; Lungs; Developmental Disorder

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of the clean intervention

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

  2 years

Secondary Outcomes (3)

• Air quality

  Up to 2 years

• Pulmonary function testing

  Up to 2 years

• Acceptability of using air filter device

  Up to 2 years

Study Arms (1)

Clean air intervention

EXPERIMENTAL

See detailed description

Other: Clean Air Intervention

Interventions

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.

Clean air intervention

Eligibility Criteria

• Age: 1 Month - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mbarara University of Science and Technology: collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Insufficiency; Developmental Disabilities

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Peter Moschovis, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jerome Kabakyenga, MBChB, MPH, PhD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Pulmonologist

Model Details: The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 13, 2023
• Study Start: May 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)