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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00114881 |
The purpose of this study is to determine the way environmental factors affect immune system development and symptoms of asthma in inner city children.
Study hypotheses: 1) Environmental factors in the inner city adversely influence the development of the immune system to promote cytokine dysregulation, allergy, and recurrent wheezing by age 3. 2) Children who have had a viral lower respiratory infection and have developed cytokine dysregulation by age 3 are at increased risk for the development of asthma by age 6.
Condition |
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Asthma Allergy |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Urban Environment and Childhood Asthma (URECA) |
Estimated Enrollment: | 500 |
Study Start Date: | January 2005 |
Groups/Cohorts |
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1
Children at high risk for developing allergic diseases and asthma, on the basis of a parental history of asthma, allergic rhinitis or atopic dermatitis, and residence in the inner city
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The prevalence of asthma has dramatically increased in recent years, particularly in inner cities. Evidence suggests that environmental factors unique to the inner city, such as certain allergens, infections, and pollutants, may affect immune system development and lead to the development of more severe asthma in early childhood. However, information on environmental effects is limited. This study will relate immune system development and early environmental influences to the development of asthma in inner city children.
This study will last 48 months and will include young children and their families. Ten phone interviews and seven study visits will occur. Phone interviews will take place at Months 6, 9, 15, 18, 21, 27, 30, 39, 42, and 45. During the interviews, families will be asked about their respiratory symptoms, environmental exposures, diet, health care utilization, medication use, and perceived stress.
Study visits will occur at a prenatal visit before the participating children are born and at Months 3, 12, 24, 33, 36, and 48. At Visit 1, mothers will complete questionnaires about their environment, stress level, demographic information, and medical history. At the time of birth, a sample of umbilical cord blood will be obtained. Visit 2 is a home visit and will occur 3 months after the mothers give birth. A home environment inspection and dust collection will be performed, as well as an assessment of respiratory symptoms and health care utilization. Monitors for nitrogen dioxide and nicotine will be placed in participants' homes for 2 weeks.
At Visits 3 and 4, blood will be collected from both mothers and their babies; mucus from the nose will be also collected from babies. Mothers will complete questionnaires about their babies' illnesses and asthma symptoms and changes in the home environment. At Visit 5, families will complete a health and environmental update and will receive a skin prick test to test for allergies. At Visit 6, blood and nasal fluid collection will occur in the children and questionnaires about the home environment will be completed by the families. A physical exam will occur at Visits 3, 4, and 6. Visit 7 will be a study close-out visit.
In addition to scheduled visits, the parents will be instructed to contact the study center at the earliest sign that their child is developing lower respiratory tract symptoms. There will be two additional times for dust collection between the child's first and third birthdays.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inner city children
Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
Exclusion Criteria for Infants:
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118 | |
United States, Missouri | |
Saint Louis Children's Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
Rho Federal System Division, Inc.- data coordinating center | |
Chapel Hill, North Carolina, United States, 27517 | |
United States, Wisconsin | |
University of Wisconsin- an administrative site | |
Madison, Wisconsin, United States, 53706 | |
University of Wisconsin- an administrative site | |
Madison, Wisconsin, United States, 53706 |
Principal Investigator: | Robert Wood, MD | Johns Hopkins University |
Principal Investigator: | George T. O'Connor, MD, MS | Boston University |
Principal Investigator: | Meyer Kattan, MD, CM | Columbia University School of Medicine |
Principal Investigator: | Gordon Bloomberg, MD | Washington University School of Medicine |
Principal Investigator: | James Gern, MD | University of Wisconsin, Madison |
Principal Investigator: | Herman Mitchell, PhD | Rho Federal System Division, Inc. |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT ICAC-07 |
Study First Received: | June 17, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00114881 |
Health Authority: | United States: Federal Government |
Children Urban Health Pregnancy Asthma |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |