Social Media and Risk-reduction Training for Preterm Infant Care Practices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Impact of the NICU safe sleep intervention on safe infant sleep position
研究概览
简要总结
SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to improve adherence to safe sleep practices among mothers of preterm infants. This study includes two complementary, culturally competent, intervention strategies and will test the effectiveness of each strategy, as well as both strategies in combination. The attention matched-control intervention will focus on shared reading.
The SMART Preemie study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages; 2) Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 3) Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 4) Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages. A total of 1600 mothers will be recruited (100/hospital), with 400 in each study group.
The primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the shared reading control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. The tertiary aim is to assess key implementation outcomes which will be used for future scale-up. With the successful completion of the SMART Preemie study, effectiveness, mechanism, and implementation data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English- or Spanish- speaking mothers of preterm infants (gestational age <37 weeks' weeks)
- •Infant must have been admitted to one of the 16 participating NICUs for at least 7 days
- •Infant must be discharged home from one of the 16 participating NICUs within 56 weeks post-menstrual age (>95% of preterm infants)
- •Infant must be discharged to the care of the mother (not a foster family) who intends to care for the child in the US for the first 6 months post-discharge
- •Must have a phone that can receive text messages and view videos
排除标准
- •Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.
- •Infant has contraindications to safe sleep positioning (e.g. extremely rare conditions of the airway or lower spine)
- •Meets the definition of a minor according to applicable state law.
研究组 & 干预措施
Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
干预措施: Safe Sleep TodaysNICUBaby videos and messages (Behavioral)
Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag
干预措施: Shared Reading NICU Quality Improvement Campaign (Behavioral)
Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag
干预措施: Shared Reading TodaysNICUBaby videos and messages (Behavioral)
Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages
干预措施: Safe Sleep NICU Quality Improvement Campaign (Behavioral)
Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages
干预措施: Shared Reading TodaysNICUBaby videos and messages (Behavioral)
Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
干预措施: Shared Reading NICU Quality Improvement Campaign (Behavioral)
Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
干预措施: Safe Sleep TodaysNICUBaby videos and messages (Behavioral)
Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
干预措施: Safe Sleep NICU Quality Improvement Campaign (Behavioral)
结局指标
主要结局
Impact of the NICU safe sleep intervention on safe infant sleep position
时间窗: 60 days post-discharge
Percent with exclusive supine sleep in the previous 2 weeks
Impact of the NICU safe sleep intervention on safe infant sleep location
时间窗: 60 days post-discharge
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Impact of the NICU safe sleep intervention safe sleep space
时间窗: 60 days post-discharge
Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)
Impact of the NICU safe sleep intervention on safe infant sleep environment
时间窗: 60 days post-discharge
Percent with absence of loose objects in the sleep area in the previous 2 weeks
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position
时间窗: 60 days post-discharge
Percent with exclusive supine sleep in the previous 2 weeks
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location
时间窗: 60 days post-discharge
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Impact of the mHealth post-discharge safe sleep intervention safe sleep space
时间窗: 60 days post-discharge
Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment
时间窗: 60 days post-discharge
Percent with absence of loose objects in the sleep area in the previous 2 weeks
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position
时间窗: 60 days post-discharge
Percent with exclusive supine sleep in the previous 2 weeks
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location
时间窗: 60 days post-discharge
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Impact of the NICU and mHealth post-discharge safe sleep intervention safe sleep space
时间窗: 60 days post-discharge
Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep environment
时间窗: 60 days post-discharge
Percent with absence of loose objects in the sleep area in the previous 2 weeks
次要结局
- Impact of the post-discharge mHealth shared reding intervention on reading(60 days post-discharge)
- Impact on the NICU and post-discharge mHealth shared reading interventions on reading(60 days post-discharge)
- Impact of the NICU shared reading intervention on early relational health(60 days post-discharge)
- Impact of the NICU shared reading intervention on reading(60 days post-discharge)
- Safe infant sleep position by maternal race/ethnicity(60 days post-discharge)
- Safe infant sleep location by maternal race/ethnicit(60 days post-discharge)
- Safe sleep space by maternal race/ethnicity(60 days post-discharge)
- Safe infant sleep environment by maternal race/ethnicity(60 days post-discharge)
- Safe infant sleep position by infant gestational age(60 days post-discharge)
- Safe infant sleep location by infant gestational age(60 days post-discharge)
- Safe sleep space by infant gestational age(60 days post-discharge)
- Safe infant sleep environment by infant gestational age(60 days post-discharge)
- Impact of the NICU safe sleep intervention on intention for safe infant sleep position(Baseline and 60 days post-discharge)
- Impact of the NICU safe sleep intervention on intention for safe infant sleep location(Baseline and 60 days post-discharge)
- Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space(Baseline and 60 days post-discharge)
- Impact of the NICU safe sleep intervention on intention for safe infant sleep environment(Baseline and 60 days post-discharge)
- Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position(60 days post-discharge)
- Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location(60 days post-discharge)
- Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space(60 days post-discharge)
- Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment(60 days post-discharge)
- Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position(60 days post-discharge)
- Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location(60 days post-discharge)
- Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space(60 days post-discharge)
- Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment(60 days post-discharge)
- Impact of the NICU safe sleep intervention on time to unsafe sleep position(0 to 60 days post-discharge)
- Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position(0 to 60 days post-discharge)
- Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position(0 to 60 days post-discharge)
- Impact of the NICU safe sleep intervention on time to unsafe sleep location(0 to 60 days post-discharge)
- Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location(0 to 60 days post-discharge)
- Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location(0 to 60 days post-discharge)
- Impact of the post-discharge mHealth shared reding intervention on early relational health(60 days post-discharge)
- Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health(60 days post-discharge)
- Reading by maternal race/ethnicity(60 days post-discharge)
- Early relational health by race/ethnicity(60 days post-discharge)
- Reading by infant gestational age(60 days post-discharge)
- Early relational health by infant gestational age(60 days post-discharge)
- Feasibility of NICU interventions(In year 4-5 of study period, after completion of enrollment on subjects)
- Acceptability of NICU interventions(In year 4-5 of study period, after completion of enrollment on subjects)
- Fidelity to NICU safe sleep intervention(Baseline)
- Fidelity to NICU shared reading intervention(Baseline)
- Fidelity to mHealth interventions(Days 1-60 post-discharge)
研究者
Margaret Parker
Professor
University of Massachusetts, Worcester