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CompletedNCT00044603Updated Oct 15, 2014

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

An observational study in Pregnancy, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
505
Ages
18 Years to 40 Years
Sex
Female
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Study 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

Read the 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.

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Conditions studied

  • Pregnancy

Keywords

  • Pregnancy
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In context

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 175 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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).

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Smoking/ illicit drugs
  • Hypertension
  • Diabetes
  • Occupational exposure
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
505 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Fetal growth

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

    Time frame: Birth

Secondary outcomes

  1. 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.

    Time frame: 3 months - 3 years

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Study locations

1 site
  • Columbia University, 722 W 168th St, 12th Floor
    New York, New York 10032, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00044603
Lead sponsor
National Institute of Environmental Health Sciences (NIEHS)
Responsible party
Sponsor
First posted
Sep 5, 2002
Start date
Feb 2000
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Oct 15, 2014

Study contacts

Frederica P Perera, DrPH, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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