Clinical trial NCT01741051: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Growth Restriction
Keywords: Air pollution
Particulate matter
Mongolia
Pregnancy
Intrauterine growth restriction (IUGR)
Fetal growth
Birth weight
Gestational age
Obesity
IQ
Autism
Wheeze
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-12-04
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Gestational-age adjusted birthweight
timeFrame: At birth
measure: Birthweight
timeFrame: At birth
measure: Gestational age
timeFrame: At birth
measure: Head circumference
timeFrame: At birth
measure: Small for gestational age
timeFrame: At birth
measure: Birth length
timeFrame: At birth
measure: Child body mass index
timeFrame: Age 2 years
measure: Child body mass index
timeFrame: Age 4 years
measure: Child wheeze
timeFrame: Annually from birth to age 4 years
measure: Child behavioural development
timeFrame: Age 2 years
measure: Child behavioural development
timeFrame: Age 4 years
measure: Child neurocognitive development
timeFrame: Age 4 years
measure: Child social development
timeFrame: Age 4 years
Secondary outcomes:
measure: Blood pressure
timeFrame: At approximately 10, 11, 30 and 31 weeks gestation
measure: C-reactive protein
timeFrame: At approximately 10 and 30 weeks gestation
measure: Stratified Analyses
timeFrame: Various
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Mongolia National University of Medical Sciences
Study officials:
affiliation: Simon Fraser University
name: Ryan Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 Oct;168:107432. doi: 10.1016/j.envint.2022.107432. Epub 2022 Jul 25.
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.
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.
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.