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试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Penetration of sign up for TodaysBaby
研究概览
简要总结
This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must speak English or Spanish
- •Must live in the United States
- •Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth
- •Must plan to care for infant and live in the same household as infant after birth
- •Must enroll in the TodaysBaby program by the time their infant is 7 days of age
排除标准
- •A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.
结局指标
主要结局
Penetration of sign up for TodaysBaby
时间窗: First week after birth
Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies
Equity of sign up for TodaysBaby
时间窗: First week after birth
Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies
次要结局
- Feasibility of implementation(Within a year of participant enrollment (qualitative) and >60 day after birth survey)
- Acceptability(Within a year of participant enrollment)
- Sustainability(Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods)
- Fidelity(First 60 days after birth)
- Effectiveness of TodaysBaby on safe sleep practices(60-180 days (average 80 days) after birth survey)
- Program cost of TodaysBaby(60-180 days during the program sign up periods.)
研究者
Rachel Moon, MD
Professor, Department of Pediatrics
University of Virginia