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

Sponsor

Simon Fraser University (Other)

Overall Status

Completed

CT.gov ID

NCT01741051

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

540

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Restriction	Device: HEPA Filter	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: HEPA Filter

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

Device: HEPA Filter

No Intervention: Control

Outcome Measures

Primary Outcome Measures

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 2 years]
BMI = weight(kg)/height(m)^2
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 2 years]
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
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

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.