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Urban Environmental Factors and Childhood Asthma (URECA)

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.
 
ClinicalTrials.gov Identifier: NCT00114881
Recruitment Status : Active, not recruiting
First Posted : June 20, 2005
Last Update Posted : October 4, 2021
Sponsor:
Collaborators:
Inner-City Asthma Consortium
Rho Federal Systems Division, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease
Asthma Allergy

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 three periods, as the subjects age from birth to 10 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.
Study Design
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Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Urban Environment and Childhood Asthma (URECA)
Actual Study Start Date : February 2, 2005
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Group/Cohort
Inner-city children with asthma
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


Outcome Measures
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Primary Outcome Measures :
  1. Development of wheezing [ Time Frame: 0 to 3 years of age ]
    Establish in inner city children the immunologic causes for the development of recurrent wheezing.

  2. Correlation of Immunologic Factors and Development of Asthma [ Time Frame: by 7 years of age ]
    Establish, in this cohort of inner-city children, the immunologic causes for the development of asthma at age 7

  3. Correlation of Risk Factors to Rapidly Evolving Asthma Phenotypes [ Time Frame: 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

  4. Incidence of Asthma [ Time Frame: up to 16 years of age ]
    Number of participants with the incidence (development) of asthma

  5. Occurrence of Specific Phenotypes of Asthma [ Time Frame: up to 16 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).


Biospecimen Retention:   Samples With DNA
  • Sample of umbilical cord blood (mother)
  • Maternal blood sample
  • Blood and nasal mucus collection (infant through age 14 or 16 years)
  • DNA sample of mother and child
  • Urine sample
  • Saliva sample
  • Induced sputum sample
  • Nasal epithelial cells sample

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inner city children
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
Contacts and Locations
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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): NCT00114881


Locations
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United States, Maryland
Pediatric Clinical Research Unit, Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Medical Center
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 Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Inner-City Asthma Consortium
Rho Federal Systems Division, Inc.
Investigators
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Study Chair: James E. Gern, MD University of Wisconsin, Madison
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00114881    
Other Study ID Numbers: DAIT ICAC-07
NIAID CRMS ID#: 20126 ( Other Identifier: DAIT NIAID )
First Posted: June 20, 2005    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Children
Urban Health
Pregnancy
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases