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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01741051
Other study ID # 275997
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 2019

Study information

Verified date January 2020
Source Simon Fraser University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 540
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
HEPA Filter


Locations

Country Name City State
Mongolia Mongolia National University of Medical Sciences Ulaanbaatar

Sponsors (2)

Lead Sponsor Collaborator
Simon Fraser University Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Mongolia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gestational-age adjusted birthweight At birth
Primary Birthweight At birth
Primary Gestational age At birth
Primary Head circumference At birth
Primary Small for gestational age <10%ile of birth weight for gestational age At birth
Primary Birth length Birth length At birth
Primary Child body mass index BMI = weight(kg)/height(m)^2 Age 2 years
Primary Child body mass index BMI = weight(kg)/height(m)^2 Age 4 years
Primary Child wheeze Parent-reported wheeze (ever/never and phenotypes) Annually from birth to age 4 years
Primary Child behavioural development Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3) Age 2 years
Primary Child behavioural development Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3) Age 4 years
Primary Child neurocognitive development Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) Age 4 years
Primary Child social development Social Responsiveness Scale, Second Edition (SRS-2) scores Age 4 years
Secondary Blood pressure At approximately 10, 11, 30 and 31 weeks gestation
Secondary C-reactive protein At approximately 10 and 30 weeks gestation
Secondary 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
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