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

Fetal Growth Restriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741051
• Other study ID #: 275997
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation

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