AsthmaNCT00043498
Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children
An observational study of Asthma and Development, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma, Development
- How many people
- 727 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1997to May 2013
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
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.
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
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.
Read the 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.
- Conditions
- Asthma, Development
- Keywords
- Pollutants
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral development
Measured: 1 to 12 years
Asthma
Measured: 2-12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startAug 1997
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 727 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
- NCT00043498
- Sponsor's protocol ID
- 8977-CP-001
- Status last verified
- Oct 2014
- First submitted
- 9 Aug 2002
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Widen EM, Whyatt RM, Hoepner LA, Ramirez-Carvey J, Oberfield SE, Hassoun A, Perera FP, Gallagher D, Rundle AG. Excessive gestational weight gain is associated with long-term body fat and weight retention at 7 y postpartum in African American and Dominican mothers with underweight, normal, and overweight prepregnancy BMI. Am J Clin Nutr. 2015 Dec;102(6):1460-7. doi: 10.3945/ajcn.115.116939. Epub 2015 Oct 21.
PubMed 26490495
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
- Health Effects of Early-Life Exposure to Urban Pollutants in Minority Children
- ClinicalTrials.gov ID
- NCT00043498
- Acronym / sponsor ID
- 8977-CP-001
- Conditions
- Asthma, Development
- Keywords
- Pollutants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 727 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Aug 1997
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 12 Aug 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
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
Neurobehavioral development
Time frame: 1 to 12 years
Asthma
Time frame: 2-12 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.
- Derived from this study: PubMed 26490495Widen EM, Whyatt RM, Hoepner LA, Ramirez-Carvey J, Oberfield SE, Hassoun A, Perera FP, Gallagher D, Rundle AG. Excessive gestational weight gain is associated with long-term body fat and weight retention at 7 y postpartum in African American and Dominican mothers with underweight, normal, and overweight prepregnancy BMI. Am J Clin Nutr. 2015 Dec;102(6):1460-7. doi: 10.3945/ajcn.115.116939. Epub 2015 Oct 21.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 Asthma and Development, 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?
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?
Neurobehavioral development (time frame: 1 to 12 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043498, which also lists 1 linked publication.
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.