Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741051
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ryan Allen, Simon Fraser University

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date January 23, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • Gestational-age adjusted birthweight [ Time Frame: At birth ]
  • Birthweight [ Time Frame: At birth ]
  • Gestational age [ Time Frame: At birth ]
  • Head circumference [ Time Frame: At birth ]
  • Small for gestational age [ Time Frame: At birth ]
    <10%ile of birth weight for gestational age
  • Birth length [ Time Frame: At birth ]
    Birth length
  • Child body mass index [ Time Frame: Age 2 years ]
    BMI = weight(kg)/height(m)^2
  • Child body mass index [ Time Frame: Age 4 years ]
    BMI = weight(kg)/height(m)^2
  • Child wheeze [ Time Frame: Annually from birth to age 4 years ]
    Parent-reported wheeze (ever/never and phenotypes)
  • Child behavioural development [ Time Frame: Age 2 years ]
    Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
  • Child behavioural development [ Time Frame: Age 4 years ]
    Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
  • 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)
  • Child social development [ Time Frame: Age 4 years ]
    Social Responsiveness Scale, Second Edition (SRS-2) scores
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Gestational-age adjusted birthweight [ Time Frame: At birth ]
  • Birthweight [ Time Frame: At birth ]
  • Gestational age [ Time Frame: At birth ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
  • Blood pressure [ Time Frame: At approximately 10, 11, 30 and 31 weeks gestation ]
  • C-reactive protein [ Time Frame: At approximately 10 and 30 weeks gestation ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Blood pressure [ Time Frame: At approximately 10, 11, 30 and 31 weeks gestation ]
  • C-reactive protein [ Time Frame: At approximately 10 and 30 weeks gestation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
Official Title  ICMJE A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Fetal Growth Restriction
Intervention  ICMJE Device: HEPA Filter
Study Arms  ICMJE
  • Experimental: HEPA Filter
    HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
    Intervention: Device: HEPA Filter
  • No Intervention: Control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
540
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mongolia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741051
Other Study ID Numbers  ICMJE 275997
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ryan Allen, Simon Fraser University
Study Sponsor  ICMJE Simon Fraser University
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Ryan Allen, PhD Simon Fraser University
PRS Account Simon Fraser University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP