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

NCT01741051 | Completed

• 1 other identifier: 275997
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (13)

• Gestational-age adjusted birthweight

  At birth

• Birthweight

  At birth

• Gestational age

  At birth

• Head circumference

  At birth

• Small for gestational age

  \<10%ile of birth weight for gestational age

  At birth

• Birth length

  Birth length

  At birth

• Child body mass index

  BMI = weight(kg)/height(m)\^2

  Age 2 years

• Child body mass index

  BMI = weight(kg)/height(m)\^2

  Age 4 years

• Child wheeze

  Parent-reported wheeze (ever/never and phenotypes)

  Annually from birth to age 4 years

• Child behavioural development

  Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)

  Age 2 years

• Child behavioural development

  Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)

  Age 4 years

• Child neurocognitive development

  Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)

  Age 4 years

• Child social development

  Social Responsiveness Scale, Second Edition (SRS-2) scores

  Age 4 years

Secondary Outcomes (3)

• Blood pressure

  At approximately 10, 11, 30 and 31 weeks gestation

• C-reactive protein

  At approximately 10 and 30 weeks gestation

• Stratified Analyses

  Various

Study Arms (2)

HEPA Filter

EXPERIMENTAL

HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.

Device: HEPA Filter

Control

NO INTERVENTION

Interventions

HEPA Filter DEVICE

HEPA Filter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years)
• Pregnant woman in first trimester (\<14 weeks)
• Single gestation pregnancy
• Non-smoker

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Fraser University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Mongolia National University of Medical Sciences

Ulaanbaatar, Mongolia

Location

Related Publications (4)

• 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.

  PMID: 36007302 DERIVED

• 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.

  PMID: 35730943 DERIVED

• 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.

  PMID: 34225757 DERIVED

• 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.

  PMID: 30213473 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation; Birth Weight; Obesity; Autistic Disorder; Respiratory Sounds

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Respiratory

Study Officials

• Ryan Allen, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

MO (1)