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Fetal Growth RestrictionNCT01741051

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

A study testing HEPA Filter in people with Fetal Growth Restriction, run by Simon Fraser University at 1 site in Mongolia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Fetal Growth Restriction
What is being tested?
HEPA Filter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteMongolia
Study dates
Jan 2014to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mongolia1 site

  • Mongolia National University of Medical Sciences

    Ulaanbaatar

Other trials in Mongolia

About this study

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.

Being tested
HEPA Filter
Keywords
Air pollution, Particulate matter, Mongolia, Pregnancy, Intrauterine growth restriction (IUGR), Fetal growth, Birth weight, Gestational age, Obesity, IQ, Autism, Wheeze
Medical subject headings
Fetal Growth Retardation, Birth Weight, Obesity, Autistic Disorder, Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEPA FilterDevice

Study groups in NCT01741051
Study groupRoleWhat they receive
HEPA FilterExperimentalHEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
Receives: Device: HEPA Filter
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational-age adjusted birthweight

    Measured: At birth

  2. Birthweight

    Measured: At birth

  3. Gestational age

    Measured: At birth

  4. Head circumference

    Measured: At birth

  5. Small for gestational age

    <10%ile of birth weight for gestational age

    Measured: At birth

  6. Birth length

    Birth length

    Measured: At birth

  7. Child body mass index

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

    Measured: Age 2 years

  8. Child body mass index

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

    Measured: Age 4 years

  9. Child wheeze

    Parent-reported wheeze (ever/never and phenotypes)

    Measured: Annually from birth to age 4 years

  10. Child behavioural development

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

    Measured: Age 2 years

  11. Child behavioural development

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

    Measured: Age 4 years

  12. Child neurocognitive development

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

    Measured: Age 4 years

  13. Child social development

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

    Measured: Age 4 years

Secondary outcomes (3)

  1. Blood pressure

    Measured: At approximately 10, 11, 30 and 31 weeks gestation

  2. C-reactive protein

    Measured: At approximately 10 and 30 weeks gestation

  3. 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.

    Measured: Various

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741051
Sponsor's protocol ID
275997
Status last verified
Jan 2020
First submitted
30 Nov 2012
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36007302

  • 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.

    PubMed 35730943

  • 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.

    PubMed 34225757

  • 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.

    PubMed 30213473

Questions about this trial

What is this clinical trial studying?

A study testing HEPA Filter in people with Fetal Growth Restriction, run by Simon Fraser University at 1 site in Mongolia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational-age adjusted birthweight (time frame: At birth). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741051, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

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