Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044603
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2002-09-03
Brief Title:
Vulnerability of the FetusInfant to PAH PM25 AND ETS
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
Vulnerability of the FetusInfant to PAH PM25 AND ETS
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to examine the effects of in utero and postnatal exposure to environmental pollutants in a cohort of pregnant women and their newborns in Krakow Poland
Detailed Description:
There is growing concern about adverse developmental effects in infants and young children from prenatal exposure to environmental air pollutants including polycyclic aromatic hydrocarbons PAH particulate matter PM25 and environmental tobacco smoke ETS The proposed study combines expertise in molecular epidemiology and biomarkers state-of- the-art pollutant monitoring techniques and a strong theoretical framework to guide assessment of the impacts of these pollutants on fetal and child growth and development The specific aims are 1 To test the hypothesis that prenatal exposure to airborne polycyclic aromatic hydrocarbons PAH adversely affects fetal growth and early childhood growth and development after controlling for non-PAH components of PM25 ETS nutritional status essential fatty acids and antioxidants and other potential confounders 2 To explore whether non-PAH components of PM25 and ETS have an independent effect on birth outcomes and childhood growth and development after controlling for PAH and to explore possible interactions between PAH PM25 and ETS and 3 To estimate the relative contribution of ambient PAH pollution vs ETS and other indoor PAH sources to a personal PAH exposure and PAH-DNA adducts and b impairment of fetal growth and early child development To achieve these aims the international team of researchers will carry out a prospective cohort study of 400 nonsmoking pregnant women living in Krakow Poland and will follow their newborns for 12 months postnatally Fetal growth will be assessed at birth by weight length head circumference and size for gestational age Childhood growth and developmental outcomes will be measured using the Fagan Test and the Bayley Scales Strengths of the research include the combination of personal inhalation monitoring of PAH and PM25 with biomarkers umbilical cord blood levels of PAH-DNA adducts cotinine essential fatty acids antioxidants and lead to estimate in utero exposure to the pollutants of interest and potential confounders The Polish cohort provides a valuable model for study since emissions from coal burning and traffic are relatively high However the results will be broadly applicable since exposures to PAH ETS and PM25 during pregnancy are common in virtually all industrialized regions of the world It is anticipated that this research will provide relevant data to policymakers concerned with protecting the health of young children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None