Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months
研究概览
简要总结
This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the patient portal of the electronic health record (EHR).
详细描述
The purpose of this study is to assess if photographs of infants sleeping at night sent by parents through the patient portal of the electronic health record (EHR) can be used to a) deliver individualized feedback on safe infant sleep surfaces and sleep health and b) improve parental knowledge of and adherence to guidelines for safe infant sleep surfaces and sleep health. The feasibility of this approach will also be assessed through a randomized, clinical trial involving 130 infants with primary care through Penn State Health. Participants will be randomized to receive personalized feedback on the infant sleep position and surface at age 1 month in addition to usual care or a usual care group. Both groups will receive personalized feedback on the infant sleep position and surface at infant age 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
2 month photographs will be evaluated by study team members blinded to the study group.
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age: ≥37 weeks
- •Singleton birth
- •Newborns ages 0 days to 14 days old
- •Newborn nursery stay <=7 days
- •English speaking mother
- •Mother ≥18 years old
- •Has email/internet access
- •Willing to sign up for the Penn State Health Patient Portal through the Electronic Health Record (EHR)
- •Owns a smart phone, digital camera, or tablet that can take pictures to be transmitted through the EHR
- •Plan to follow with a Penn State Health Provider though the infant's 3-4 month well child visit
排除标准
- •Maternal morbidity or pre-existing condition that affects ability to care for the newborn (e.g. narcotic drug use, chemotherapy, uncontrolled depression etc.)
- •Child is being adopted or will not be in the care of the mother
研究组 & 干预措施
intervention at 1 month + usual care
Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months.
干预措施: Safe (Behavioral)
usual care
Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months.
干预措施: Safe (Behavioral)
结局指标
主要结局
percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months
时间窗: 2 months of age
Safe sleep environment will include: 1. Solitary vs. non-solitary sleep 2. Supine vs. non-supine infant sleep position 3. No loose objects vs. loose objects on the sleep surface 4. Tight-bedding vs. loose-bedding 5. Firm vs. soft sleep surface (i.e. crib/bassinete vs. sofa/bouncy chair) 6. Infant's sleeping in same room as parents vs. separate room 7. No head coverings vs. head coverings
次要结局
- Parent compliance(1 and 2 months of age)
研究者
Ian M. Paul, MD
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Faculty Affairs, Department of Pediatrics
Milton S. Hershey Medical Center