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

January 21, 2020 updated by: Ryan Allen, Simon Fraser University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mongolia
      • Ulaanbaatar, Mongolia
        • Mongolia National University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: At approximately 10, 11, 30 and 31 weeks gestation
At approximately 10, 11, 30 and 31 weeks gestation
C-reactive protein
Time Frame: At approximately 10 and 30 weeks gestation
At approximately 10 and 30 weeks gestation
Stratified Analyses
Time Frame: 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.
Various

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Fraser University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Ryan Allen, PhD, Simon Fraser University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275997

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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