A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Simon Fraser University
- Enrollment
- 540
- Locations
- 1
- Primary Endpoint
- Child wheeze
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult (>18 years)
- •Pregnant woman in first trimester (<14 weeks)
- •Single gestation pregnancy
- •Non-smoker
Exclusion Criteria
- •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
Arms & Interventions
HEPA Filter
HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
Intervention: HEPA Filter (Device)
Control
Outcomes
Primary Outcomes
Child wheeze
Time Frame: Annually from birth to age 4 years
Parent-reported wheeze (ever/never and phenotypes)
Child behavioural development
Time Frame: Age 4 years
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Child neurocognitive development
Time Frame: Age 4 years
Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)
Child social development
Time Frame: Age 4 years
Social Responsiveness Scale, Second Edition (SRS-2) scores
Gestational-age adjusted birthweight
Time Frame: At birth
Birthweight
Time Frame: At birth
Gestational age
Time Frame: At birth
Head circumference
Time Frame: At birth
Small for gestational age
Time Frame: At birth
\<10%ile of birth weight for gestational age
Birth length
Time Frame: At birth
Birth length
Child body mass index
Time Frame: Age 4 years
BMI = weight(kg)/height(m)\^2
Child body mass index
Time Frame: Age 2 years
BMI = weight(kg)/height(m)\^2
Child behavioural development
Time Frame: Age 2 years
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Secondary Outcomes
- Blood pressure(At approximately 10, 11, 30 and 31 weeks gestation)
- C-reactive protein(At approximately 10 and 30 weeks gestation)
- Stratified Analyses(Various)
Investigators
Ryan Allen
Associate Professor
Simon Fraser University