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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044603
• Other study ID #: 10165-CP-001
• Status: Completed
• Phase: N/A
• First received: September 3, 2002
• Last updated: October 14, 2014
• Start date: February 2000
• Est. completion date: January 2006

Study information

• Verified date: October 2014
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	Columbia University, 722 W 168th St, 12th Floor	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal growth	Fetal growth is assessed at birth by weight, length, head circumference, and size for gestational age	Birth	No
Secondary	Childhood growth and neurodevelopmental outcomes	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.	3 months - 3 years	No