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Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043498
First Posted: August 12, 2002
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Environmental Health Sciences (NIEHS)
  Purpose
A molecular epidemiologic study of African American and Hispanic mothers and newborns to investigate the role of common urban pollutants on procarcinogenic and developmental damage.

Condition
Asthma Development

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Primary Outcome Measures:
  • Neurobehavioral development [ Time Frame: 1 to 12 years ]
  • Asthma [ Time Frame: 2-12 years ]

Biospecimen Retention:   Samples With DNA
We collected maternal urine during the third trimester of pregnancy, maternal blood at delivery, umbilical cord blood, meconium, blood and urine from the child at ages 24, 36, and 60 months.

Enrollment: 727
Study Start Date: August 1997
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed Description:
The major objective of the proposed research is to study the impact of early-life exposures to common urban pollutants on neurobehavioral development and asthma in a sample of children living in three low-income, minority communities of New York City (Central Harlem, Washington Heights and the South Bronx). Using a molecular epidemiologic approach with monitoring, biomarkers, and clinical assessments at serial time points, we will extend our study of African-American and Latina urban mothers and children in order to follow the cohort through child age 11 years to assess the longer-term impact of exposures on child health and developmental outcomes.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The present study enrolled 727 African American and Latino (Dominican) mothers and their children. The African American and Latino (Dominican) women were initially enrolled into the parent CCCEH study during pregnancy. Caucasian women are not included because a central purpose of the research is to evaluate health outcomes in a high risk, minority population.
Criteria
Enrollment eligibility was restricted to nonsmoking pregnant women 18-35 years of age who self-identified as either African American or Dominican and who had resided in northern Manhattan or the South Bronx in New York City for at least 1 year before pregnancy. Women were excluded if they used illicit drugs, had diabetes, hypertension, or known HIV, or had their first prenatal visit after the 20th week of pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043498


Locations
United States, New York
Columbia University, 722 W 168th St, 12th Floor
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: Frederica P Perera, DrPH, PhD Columbia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00043498     History of Changes
Other Study ID Numbers: 8977-CP-001
First Submitted: August 9, 2002
First Posted: August 12, 2002
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Pollutants


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