Allergy, Asthma
Conditions
Keywords
Children, Urban Health, Pregnancy, Asthma
Brief summary
Minority children who grow up in poor urban neighborhoods have the highest rates of asthma, and also experience greater morbidity from acute exacerbations of this disease. The aim of this study is to further identify environmental factors unique to the inner city that affect immune development and the expression of wheezing, atopy and asthma for purposes of identifying new strategies for asthma prevention.
Detailed description
The purpose of this study is to determine the way environmental factors (like the components of inner-city household dust) affect immune system development and symptoms of asthma in inner city children. The study is divided into five periods, as the subjects age from birth to 17 years old. Each age bracket will explore different objectives and endpoints. Study Objectives/Hypotheses: 1. Subjects age 0 to 3 years old: * 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. * 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. 2. Subjects age 4 to 7 years old: * There is a unique pattern of immune development that is driven by specific urban exposures in early life, and this pattern of immune development is characterized by: 1) impairment of antiviral responses and 2) accentuation of Th2-like responses (e.g. cockroach-specific Interleukin-13(IL-13)). The clinical effects of these changes in immune development are frequent virus-induced wheezing and allergic sensitization by 3-4 years of age, and these characteristics synergistically increase the risk of asthma at age 7 years. 3. Subjects age 7 to 10 years old: * There are unique combinations of environmental exposures (cockroach allergens, indoor pollutants \[Environmental Tobacco Smoke (ETS) and Nitrogen Dioxide (NO2)\], lack of microbial exposure), and family characteristics (stress, genetic factors related to innate immunity) that synergistically promote asthma onset, persistence, and morbidity in urban neighborhoods. These exposures and characteristics influence immune expression and lung development during critical periods of growth, resulting in specific asthma phenotypes. 4. Subjects age 10 to 16 years old: -To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence. 5. Subjects to age 17 (Continuation of phase 4 to follow participants to age 17) To determine the wheezing, asthma and atopy phenotypes in minority children growing up in poor urban neighborhoods as they develop from birth through adolescence.
Interventions
None listed
Sponsors
Inner-City Asthma Consortium
Rho Federal Systems Division, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
for Mothers: * Plan to give birth at the study hospital * Have asthma, hay fever, or eczema (or infant's father has any of these diseases) * Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level * At least 34 weeks pregnant at time of delivery * Willing to allow an umbilical cord blood specimen to be obtained from her infant * Willing to comply with all study requirements * Have access to a phone * Speak English. Spanish-speaking participants enrolled at sites with Spanish-speaking staff are also eligible.
Exclusion criteria
for Mothers: * HIV infected at the time of delivery * Plan to move out of the geographic area during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of wheezing | 0 to 3 years of age | Establish in inner city children the immunologic causes for the development of recurrent wheezing. |
| Correlation of Immunologic Factors and Development of Asthma | by 7 years of age | Establish, in this cohort of inner-city children, the immunologic causes for the development of asthma at age 7 |
| Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes | up to 10 years of age | Fully define the rapidly evolving asthma phenotypes and further delineate the role of risk factors related to environmental exposure (e.g.; house dust levels found through home inspection), immune development, lung growth on the natural history of asthma and allergic diseases in urban minority children |
| Incidence of Asthma | up to 17 years of age | Number of participants with the incidence (development) of asthma |
| Occurrence of Specific Phenotypes of Asthma | up to 17 years of age | Further define asthma phenotypes based on the findings in Inner-city Asthma Consortium-19 (ICAC-19) (Asthma Phenotypes in the Inner City (APIC), ClinicalTrials.gov Identifier NCT01383941). |
Countries
United States
Outcome results
None listed