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NCT Number: NCT01741051

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mongolia National University of Medical Sciences

Ulaanbaatar, Mongolia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEPA Filter

Device

Primary outcomes

  1. Gestational-age adjusted birthweight

    Time frame: At birth

  2. Birthweight

    Time frame: At birth

  3. Gestational age

    Time frame: At birth

  4. Head circumference

    Time frame: At birth

  5. Small for gestational age

    Time frame: At birth

    <10%ile of birth weight for gestational age

  6. Birth length

    Time frame: At birth

    Birth length

  7. Child body mass index

    Time frame: Age 2 years

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

  8. Child body mass index

    Time frame: Age 4 years

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

  9. Child wheeze

    Time frame: Annually from birth to age 4 years

    Parent-reported wheeze (ever/never and phenotypes)

  10. Child behavioural development

    Time frame: Age 2 years

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

  11. Child behavioural development

    Time frame: Age 4 years

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

  12. Child neurocognitive development

    Time frame: Age 4 years

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

  13. Child social development

    Time frame: Age 4 years

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

Secondary outcomes

  1. Blood pressure

    Time frame: At approximately 10, 11, 30 and 31 weeks gestation

  2. C-reactive protein

    Time frame: At approximately 10 and 30 weeks gestation

  3. Stratified Analyses

    Time frame: Various

    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.

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2012
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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