Skip to main content
OpenTrials
Completed

NCT Number: NCT00044603

Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS.

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University, 722 W 168th St, 12th Floor

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fetal growth

    Time frame: Birth

    Fetal growth is assessed at birth by weight, length, head circumference, and size for gestational age

Secondary outcomes

  1. Childhood growth and neurodevelopmental outcomes

    Time frame: 3 months - 3 years

    At 6 months of age, information regarding physical growth was collected from pediatric assessment and neurobehavioral development was evaluated using the Fagan Test of Infant Intelligence. At one year of age and annual time intervals thereafter, physical growth was assessed during a pediatric examination and neurobehavioral development was assessed with the Bayley Scales of Infant Development.

Sponsors and collaborators

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS)

Nih

Registry information

Official study title

Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Sep 5, 2002
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.