Clinical trial NCT00114881: Urban Environmental Factors and Childhood Asthma
Official title: Urban Environment and Childhood Asthma (URECA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergy
Keywords: Children
Urban Health
Pregnancy
Asthma
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Inner-City Asthma Consortium
name: Rho Federal Systems Division, Inc.
First posted: 2005-06-20
Enrollment: 560
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inner city children

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.

Eligibility criteria: 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

Exclusion Criteria for Infants:

* Respiratory distress requiring intubation and ventilation for 4 hours or more
* Respiratory distress requiring either supplemental oxygen or continuous positive airway pressure (CPAP) for 4 days or more
* Pneumonia requiring antibiotic treatment for 1 week or more
* Significant congenital abnormality
* Received palivizumab for respiratory syncytial virus prophylaxis

Primary outcomes:
measure: Development of wheezing
timeFrame: 0 to 3 years of age
measure: Correlation of Immunologic Factors and Development of Asthma
timeFrame: by 7 years of age
measure: Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes
timeFrame: up to 10 years of age
measure: Incidence of Asthma
timeFrame: up to 17 years of age
measure: Occurrence of Specific Phenotypes of Asthma
timeFrame: up to 17 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pediatric Clinical Research Unit, Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: University of Wisconsin, Madison
name: James E. Gern, MD
role: STUDY_CHAIR
References:
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