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Urban Environmental Factors and Childhood Asthma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Inner-City Asthma Consortium
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00114881
  Purpose

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
Asthma
Allergy

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Urban Environment and Childhood Asthma (URECA)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Establish in inner city children the immunologic causes for the development of recurrent wheezing. [ Time Frame: By 36 months of age ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:
  • Sample of umbilical cord blood (mother)
  • Home environment inspection (environment)
  • Dust collection (environment)
  • Allergy test (infant)
  • Blood and nasal fluid collection (infant)

Estimated Enrollment: 500
Study Start Date: January 2005
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114881

Locations
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
Sponsors and Collaborators
Inner-City Asthma Consortium
Investigators
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.
  More Information

Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Children
Urban Health
Pregnancy
Asthma

Study placed in the following topic categories:
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009