PregnancyNCT00044603
Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS.
An observational study of Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Pregnant women between 18 and 40 years old
- Resided for at least 1 year within proximity to air monitoring station
Who cannot join
- Smoking/ illicit drugs
- Hypertension
- Diabetes
- Occupational exposure
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University, 722 W 168th St, 12th Floor
New York, New York, 10032
About this study
Official title: 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
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.
- Conditions
- Pregnancy
- Keywords
- Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal growth
Fetal growth is assessed at birth by weight, length, head circumference, and size for gestational age
Measured: 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.
Measured: 3 months - 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2002 (estimated)
- Study startFeb 2000
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frederica P Perera, DrPH, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044603
- Sponsor's protocol ID
- 10165-CP-001
- Status last verified
- Oct 2014
- First submitted
- 3 Sep 2002
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulnerability of the Fetus/Infant to PAH, PM2.5 AND ETS
- ClinicalTrials.gov ID
- NCT00044603
- Acronym / sponsor ID
- 10165-CP-001
- Conditions
- Pregnancy
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Feb 2000
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 5 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- Pregnant women between 18 and 40 years old
- Resided for at least 1 year within proximity to air monitoring station
Key exclusion criteria (4 listed)
- Smoking/ illicit drugs
- Hypertension
- Diabetes
- Occupational exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal growth
Time frame: Birth
Fetal growth is assessed at birth by weight, length, head circumference, and size for gestational age
1 secondary outcome
Childhood growth and neurodevelopmental outcomes
Time frame: 3 months - 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederica P Perera, DrPH, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal growth (time frame: Birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.