A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
Primary Purpose
Fetal Growth Restriction
Status
Completed
Phase
Not Applicable
Locations
Mongolia
Study Type
Interventional
Intervention
HEPA Filter
Sponsored by
About this trial
This is an interventional prevention trial for Fetal Growth Restriction focused on measuring Air pollution, Particulate matter, Mongolia, Pregnancy, Intrauterine growth restriction (IUGR), Fetal growth, Birth weight, Gestational age, Obesity, IQ, Autism, Wheeze
Eligibility Criteria
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
Sites / Locations
- Mongolia National University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HEPA Filter
Control
Arm Description
HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
Outcomes
Primary Outcome Measures
Gestational-age adjusted birthweight
Birthweight
Gestational age
Head circumference
Small for gestational age
<10%ile of birth weight for gestational age
Birth length
Birth length
Child body mass index
BMI = weight(kg)/height(m)^2
Child body mass index
BMI = weight(kg)/height(m)^2
Child wheeze
Parent-reported wheeze (ever/never and phenotypes)
Child behavioural development
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Child behavioural development
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Child neurocognitive development
Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)
Child social development
Social Responsiveness Scale, Second Edition (SRS-2) scores
Secondary Outcome Measures
Blood pressure
C-reactive protein
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.
Full Information
NCT ID
NCT01741051
First Posted
November 30, 2012
Last Updated
January 21, 2020
Sponsor
Simon Fraser University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01741051
Brief Title
A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
Official Title
A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Restriction
Keywords
Air pollution, Particulate matter, Mongolia, Pregnancy, Intrauterine growth restriction (IUGR), Fetal growth, Birth weight, Gestational age, Obesity, IQ, Autism, Wheeze
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEPA Filter
Arm Type
Experimental
Arm Description
HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
HEPA Filter
Primary Outcome Measure Information:
Title
Gestational-age adjusted birthweight
Time Frame
At birth
Title
Birthweight
Time Frame
At birth
Title
Gestational age
Time Frame
At birth
Title
Head circumference
Time Frame
At birth
Title
Small for gestational age
Description
<10%ile of birth weight for gestational age
Time Frame
At birth
Title
Birth length
Description
Birth length
Time Frame
At birth
Title
Child body mass index
Description
BMI = weight(kg)/height(m)^2
Time Frame
Age 2 years
Title
Child body mass index
Description
BMI = weight(kg)/height(m)^2
Time Frame
Age 4 years
Title
Child wheeze
Description
Parent-reported wheeze (ever/never and phenotypes)
Time Frame
Annually from birth to age 4 years
Title
Child behavioural development
Description
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Time Frame
Age 2 years
Title
Child behavioural development
Description
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Time Frame
Age 4 years
Title
Child neurocognitive development
Description
Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)
Time Frame
Age 4 years
Title
Child social development
Description
Social Responsiveness Scale, Second Edition (SRS-2) scores
Time Frame
Age 4 years
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
At approximately 10, 11, 30 and 31 weeks gestation
Title
C-reactive protein
Time Frame
At approximately 10 and 30 weeks gestation
Title
Stratified Analyses
Description
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.
Time Frame
Various
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Allen, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongolia National University of Medical Sciences
City
Ulaanbaatar
Country
Mongolia
12. IPD Sharing Statement
Citations:
PubMed Identifier
36007302
Citation
Enkhbat U, Gombojav E, Banzrai C, Batsukh S, Boldbaatar B, Enkhtuya E, Bellinger DC, Lanphear BP, McCandless LC, Allen RW. Portable HEPA filter air cleaner use during pregnancy and children's autistic behaviors at four years of age: The UGAAR randomized controlled trial. Environ Int. 2022 Jul 25;168:107432. doi: 10.1016/j.envint.2022.107432. Online ahead of print.
Results Reference
derived
PubMed Identifier
35730943
Citation
Ulziikhuu B, Gombojav E, Banzrai C, Batsukh S, Enkhtuya E, Boldbaatar B, Bellinger DC, Lanphear BP, McCandless LC, Tamana SK, Allen RW. Portable HEPA Filter Air Cleaner Use during Pregnancy and Children's Cognitive Performance at Four Years of Age: The UGAAR Randomized Controlled Trial. Environ Health Perspect. 2022 Jun;130(6):67006. doi: 10.1289/EHP10302. Epub 2022 Jun 22.
Results Reference
derived
PubMed Identifier
34225757
Citation
Enkhbat U, Gombojav E, Banzrai C, Batsukh S, Boldbaatar B, Enkhtuya E, Ochir C, Bellinger DC, Lanphear BP, McCandless LC, Allen RW. Portable HEPA filter air cleaner use during pregnancy and children's behavior problem scores: a secondary analysis of the UGAAR randomized controlled trial. Environ Health. 2021 Jul 5;20(1):78. doi: 10.1186/s12940-021-00763-6.
Results Reference
derived
PubMed Identifier
30213473
Citation
Barn P, Gombojav E, Ochir C, Boldbaatar B, Beejin B, Naidan G, Galsuren J, Legtseg B, Byambaa T, Hutcheon JA, Janes C, Janssen PA, Lanphear BP, McCandless LC, Takaro TK, Venners SA, Webster GM, Allen RW. The effect of portable HEPA filter air cleaner use during pregnancy on fetal growth: The UGAAR randomized controlled trial. Environ Int. 2018 Dec;121(Pt 1):981-989. doi: 10.1016/j.envint.2018.08.036. Epub 2018 Sep 10.
Results Reference
derived
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A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
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