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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01741051
Enrollment
540
Registered
2012-12-04
Start date
2014-01-31
Completion date
2019-12-31
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Restriction

Keywords

Air pollution, Particulate matter, Mongolia, Pregnancy, Intrauterine growth restriction (IUGR), Fetal growth, Birth weight, Gestational age, Obesity, IQ, Autism, Wheeze

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.

Interventions

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Simon Fraser University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Child social developmentAge 4 yearsSocial Responsiveness Scale, Second Edition (SRS-2) scores
Child wheezeAnnually from birth to age 4 yearsParent-reported wheeze (ever/never and phenotypes)
Child behavioural developmentAge 2 yearsSub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Child neurocognitive developmentAge 4 yearsSub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)
Gestational-age adjusted birthweightAt birth
BirthweightAt birth
Gestational ageAt birth
Head circumferenceAt birth
Small for gestational ageAt birth\<10%ile of birth weight for gestational age
Birth lengthAt birthBirth length
Child body mass indexAge 2 yearsBMI = weight(kg)/height(m)\^2

Secondary

MeasureTime frameDescription
C-reactive proteinAt approximately 10 and 30 weeks gestation
Stratified AnalysesVariousFor 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.
Blood pressureAt approximately 10, 11, 30 and 31 weeks gestation

Countries

Mongolia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026