NCT00624429UnknownPhase 4
A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
Phoenix Children's Hospital1 site in 1 country20 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Phoenix Children's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- FEV0.5
Study Overview
Brief Summary
The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is:
To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations).
To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.
Exclusion Criteria
- •Children less than 12 months or greater than 36 months of age.
- •Children diagnosed with attention deficit disorder by a physician or psychologist.
Outcomes
Primary Outcomes
FEV0.5
Time Frame: 2 months and 6 months into study
Secondary Outcomes
- emergency room visits(number of visits from baseline to 2 months and 2 months to 6months of study)
- behavior scores(measured at baseline, 2 months and 6 months)
- number of asthma exacerbations from baseline to 2 months and 2 months to 6 months(6 months)
Investigators
Study Sites (1)
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