Clinical trial NCT00044603: Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS.
Official title: Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-09-05
Enrollment: 505
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only Polish and Caucasian women and their children are included in the study. There are no race/ethnic minorities included because the Krakow population is ethnically and racially homogeneous (almost 100% Caucasian).

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 (PM2.5), 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 PM2.5, ETS, nutritional status (essential fatty acids and antioxidants) and other potential confounders; 2. To explore whether non-PAH components of PM2.5, 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, PM2.5 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 PM2.5 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 PM2.5 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.

Eligibility criteria: Inclusion criteria:

* Pregnant women between 18 and 40 years old
* Resided for at least 1 year within proximity to air monitoring station

Exclusion criteria:

* Smoking/ illicit drugs
* Hypertension
* Diabetes
* Occupational exposure

Primary outcomes:
measure: Fetal growth
timeFrame: Birth
Secondary outcomes:
measure: Childhood growth and neurodevelopmental outcomes
timeFrame: 3 months - 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, 722 W 168th St, 12th Floor
state: New York
Study officials:
affiliation: Columbia University
name: Frederica P Perera, DrPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: