A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community

Conditions
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Fetal Growth Restriction

Intervention / Treatment
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* Device: HEPA Filter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPA Filter<br>HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth. | Device: HEPA Filter<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational-age adjusted birthweight |  | At birth | 
| Birthweight |  | At birth | 
| Gestational age |  | At birth | 
| Head circumference |  | At birth | 
| Small for gestational age | <10%ile of birth weight for gestational age | At birth | 
| Birth length | Birth length | At birth | 
| Child body mass index | BMI = weight(kg)/height(m)^2 | Age 2 years | 
| Child body mass index | BMI = weight(kg)/height(m)^2 | Age 4 years | 
| Child wheeze | Parent-reported wheeze (ever/never and phenotypes) | Annually from birth to age 4 years | 
| Child behavioural development | Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3) | Age 2 years | 
| Child behavioural development | Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3) | Age 4 years | 
| Child neurocognitive development | Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) | Age 4 years | 
| Child social development | Social Responsiveness Scale, Second Edition (SRS-2) scores | Age 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | At approximately 10, 11, 30 and 31 weeks gestation | 
| C-reactive protein |  | At approximately 10 and 30 weeks gestation | 
| Stratified Analyses | For all variables, we will explore effect modification by maternal exposure to environmental tobacco smoke, fraction of time spent at home, sex of the baby, season of birth, gestational age at birth, and the fraction of time that the HEPA filter(s) were used. | Various | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Air pollution, Particulate matter, Mongolia, Pregnancy, Intrauterine growth restriction (IUGR), Fetal growth, Birth weight, Gestational age, Obesity, IQ, Autism, Wheeze