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.

Condition
Asthma Allergy

Further Study Details: 

Expected Total Enrollment:  500

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 36 months and will include young children and their families. Seven phone interviews and 6 study visits will occur. Phone interviews will take place at Months 6, 9, 15, 18, 21, 27, and 30. 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, and 36. 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.

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 2 additional times for dust collection between the child''''s 1st and 3rd birthdays.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00114881

Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
Massachusetts
      Boston University School of Medicine, Boston,  Massachusetts,  02118,  United States; Recruiting
Missouri
      Saint Louis Children''''s Hospital, Saint Louis,  Missouri,  United States; Recruiting
New York
      Mount Sinai, New York,  New York,  10029,  United States; Recruiting
North Carolina
      Rho Federal System Division, Inc.- data coordinating center, Chapel Hill,  North Carolina,  United States; Not yet recruiting
Wisconsin
      University of Wisconsin- an administrative site, Madison,  Wisconsin,  53706,  United States; Not yet recruiting
      University of Wisconsin- an administrative site, Madison,  Wisconsin,  53706,  United States; No longer recruiting

Study chairs or principal investigators

Peyton Eggleston, MD,  Principal Investigator,  Johns Hopkins University   
George T. O''''Connor, MD, MS,  Principal Investigator,  Boston University School of Medicine   
Meyer Kattan, MD, CM,  Principal Investigator,  Mount Sinai School of Medicine   
Gordon Bloomberg, MD,  Principal Investigator,  Washington University School of Medicine   
James Gern, MD,  Principal Investigator,  University of Wisconsin   
Herman Mitchell, PhD,  Principal Investigator,  Rho Federal System Division, Inc.   

Study ID Numbers:  DAIT ICAC-07
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 17, 2005
ClinicalTrials.gov Identifier:  NCT00114881
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05