A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Child wheeze
研究概览
简要总结
The purpose of this study is to use an air filter intervention to evaluate the relationship between particulate matter air pollution exposure during pregnancy and fetal growth. We hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major reductions in home indoor concentrations of particulate matter and 2) pregnant women whose exposures to particulate matter are reduced by this intervention will give birth to children with greater mean body weight for gestational age.
In an extended follow-up of this cohort, we aim to evaluate the relationship between use of portable air purifiers during pregnancy and the growth and development of children from birth to age four years. In particular, the follow-up study will focus on children's physical growth, respiratory symptoms, and behavioral, social and neurocognitive development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult (>18 years)
- •Pregnant woman in first trimester (<14 weeks)
- •Single gestation pregnancy
- •Non-smoker
排除标准
- •Multiple-gestation pregnancy
- •Current smoker
- •Currently operating an air filter in the home
- •Currently living in a ger (traditional Mongolian felt-lined yurt)
- •Plan to give birth outside of a hospital or clinic in Ulaanbaatar
研究组 & 干预措施
HEPA Filter
HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
干预措施: HEPA Filter (Device)
Control
结局指标
主要结局
Child wheeze
时间窗: Annually from birth to age 4 years
Parent-reported wheeze (ever/never and phenotypes)
Child behavioural development
时间窗: Age 4 years
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Child neurocognitive development
时间窗: Age 4 years
Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)
Child social development
时间窗: Age 4 years
Social Responsiveness Scale, Second Edition (SRS-2) scores
Gestational-age adjusted birthweight
时间窗: At birth
Birthweight
时间窗: At birth
Gestational age
时间窗: At birth
Head circumference
时间窗: At birth
Small for gestational age
时间窗: At birth
\<10%ile of birth weight for gestational age
Birth length
时间窗: At birth
Birth length
Child body mass index
时间窗: Age 4 years
BMI = weight(kg)/height(m)\^2
Child body mass index
时间窗: Age 2 years
BMI = weight(kg)/height(m)\^2
Child behavioural development
时间窗: Age 2 years
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
次要结局
- Blood pressure(At approximately 10, 11, 30 and 31 weeks gestation)
- C-reactive protein(At approximately 10 and 30 weeks gestation)
- Stratified Analyses(Various)
研究者
Ryan Allen
Associate Professor
Simon Fraser University