A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FEV0.5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 36 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.
排除标准
- •Children less than 12 months or greater than 36 months of age.
- •Children diagnosed with attention deficit disorder by a physician or psychologist.
结局指标
主要结局
FEV0.5
时间窗: 2 months and 6 months into study
次要结局
- 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)
