An interventional study of HEPA Filter in Fetal Growth Restriction, sponsored by Simon Fraser University. Completed at 1 site in Mongolia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Simon Fraser University · Not applicable, Interventional, and Prevention
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.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's enrollment of 540 is above the median of 150 across 110 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Simon Fraser University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.
Device: HEPA Filter
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
\<10%ile of birth weight for gestational age
Time frame: At birth
Birth length
Birth length
Time frame: At birth
Child body mass index
BMI = weight(kg)/height(m)\^2
Time frame: Age 2 years
Child body mass index
BMI = weight(kg)/height(m)\^2
Time frame: Age 4 years
Child wheeze
Parent-reported wheeze (ever/never and phenotypes)
Time frame: 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)
Time frame: Age 2 years
Child behavioural development
Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)
Time frame: Age 4 years
Child neurocognitive development
Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)
Time frame: Age 4 years
Child social development
Social Responsiveness Scale, Second Edition (SRS-2) scores
Time frame: Age 4 years
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
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.
Time frame: Various
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Simon Fraser University