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

Not Applicable

Completed

• Conditions: Fetal Growth Restriction
• Interventions: Device: HEPA Filter

• Registration Number: NCT01741051
• Lead Sponsor: Simon Fraser University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Study Start: 2014-01
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEPA Filter	HEPA Filter	HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood pressure	At approximately 10, 11, 30 and 31 weeks gestation
C-reactive protein	At approximately 10 and 30 weeks gestation
Stratified Analyses	Various	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.

Trial Locations

Locations (1)

Mongolia National University of Medical Sciences; 🇲🇳 Ulaanbaatar, Mongolia