Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 7:31 PM
Study NCT ID:
NCT01741051
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2012-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational-age adjusted birthweight', 'timeFrame': 'At birth'}, {'measure': 'Birthweight', 'timeFrame': 'At birth'}, {'measure': 'Gestational age', 'timeFrame': 'At birth'}, {'measure': 'Head circumference', 'timeFrame': 'At birth'}, {'measure': 'Small for gestational age', 'timeFrame': 'At birth', 'description': '\\<10%ile of birth weight for gestational age'}, {'measure': 'Birth length', 'timeFrame': 'At birth', 'description': 'Birth length'}, {'measure': 'Child body mass index', 'timeFrame': 'Age 2 years', 'description': 'BMI = weight(kg)/height(m)\\^2'}, {'measure': 'Child body mass index', 'timeFrame': 'Age 4 years', 'description': 'BMI = weight(kg)/height(m)\\^2'}, {'measure': 'Child wheeze', 'timeFrame': 'Annually from birth to age 4 years', 'description': 'Parent-reported wheeze (ever/never and phenotypes)'}, {'measure': 'Child behavioural development', 'timeFrame': 'Age 2 years', 'description': 'Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)'}, {'measure': 'Child behavioural development', 'timeFrame': 'Age 4 years', 'description': 'Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)'}, {'measure': 'Child neurocognitive development', 'timeFrame': 'Age 4 years', 'description': 'Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)'}, {'measure': 'Child social development', 'timeFrame': 'Age 4 years', 'description': 'Social Responsiveness Scale, Second Edition (SRS-2) scores'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'At approximately 10, 11, 30 and 31 weeks gestation'}, {'measure': 'C-reactive protein', 'timeFrame': 'At approximately 10 and 30 weeks gestation'}, {'measure': 'Stratified Analyses', 'timeFrame': 'Various', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Air pollution', 'Particulate matter', 'Mongolia', 'Pregnancy', 'Intrauterine growth restriction (IUGR)', 'Fetal growth', 'Birth weight', 'Gestational age', 'Obesity', 'IQ', 'Autism', 'Wheeze'], 'conditions': ['Fetal Growth Restriction']}, 'referencesModule': {'references': [{'pmid': '36007302', 'type': 'DERIVED', 'citation': "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': '35730943', 'type': 'DERIVED', 'citation': "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': '34225757', 'type': 'DERIVED', 'citation': "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': '30213473', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 years)\n* Pregnant woman in first trimester (\\<14 weeks)\n* Single gestation pregnancy\n* Non-smoker\n\nExclusion Criteria:\n\n* Multiple-gestation pregnancy\n* Current smoker\n* Currently operating an air filter in the home\n* Currently living in a ger (traditional Mongolian felt-lined yurt)\n* Plan to give birth outside of a hospital or clinic in Ulaanbaatar'}, 'identificationModule': {'nctId': 'NCT01741051', 'briefTitle': 'A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community', 'organization': {'class': 'OTHER', 'fullName': 'Simon Fraser University'}, 'officialTitle': 'A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community', 'orgStudyIdInfo': {'id': '275997'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEPA Filter', 'description': "HEPA filter(s) placed in the participant's home from approximately 10 weeks gestation until birth.", 'interventionNames': ['Device: HEPA Filter']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'HEPA Filter', 'type': 'DEVICE', 'armGroupLabels': ['HEPA Filter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'country': 'Mongolia', 'facility': 'Mongolia National University of Medical Sciences', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'overallOfficials': [{'name': 'Ryan Allen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simon Fraser University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simon Fraser University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ryan Allen', 'investigatorAffiliation': 'Simon Fraser University'}}}}