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A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children

Phase 4
Conditions
Asthma
Registration Number
NCT00624429
Lead Sponsor
Phoenix Children's Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
FEV0.52 months and 6 months into study
Secondary Outcome Measures
NameTimeMethod
emergency room visitsnumber of visits from baseline to 2 months and 2 months to 6months of study
behavior scoresmeasured at baseline, 2 months and 6 months
number of asthma exacerbations from baseline to 2 months and 2 months to 6 months6 months

Trial Locations

Locations (1)

Phoenix Children's Hospital

🇺🇸

Phoenix, Arizona, United States

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