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临床试验/NCT05724082
NCT05724082Enrolling By Invitation不适用

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

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
25
试验地点
1
主要终点
Feasibility and acceptability of the clean intervention

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Month 至 11 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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,

结局指标

主要结局

Feasibility and acceptability of the clean intervention

时间窗: 2 years

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

次要结局

  • Acceptability of using air filter device(Up to 2 years)
  • Pulmonary function testing(Up to 2 years)
  • Air quality(Up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Moschovis

Principal Investigator, Pediatric Pulmonologist

Massachusetts General Hospital

研究点 (1)

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