Improving Infant Sleep Safety With the Electronic Health Record
2019年10月9日 更新者：Ian M. Paul, MD、Milton S. Hershey Medical Center
Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
130
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State Milton S Hershey Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 2周 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
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Feedback, according to the 2016 national American Academy of Pediatrics (AAP) guidelines on Sudden Unexplained Infant Death (SUID) risk factors, will be generated by the study team and communicated with parents.
Feedback will be given to parents in the intervention group at ages 1 and 2 months.
The control group parents will only receive this feedback at age 2 months.
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安慰剂比较：usual care
Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months.
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Feedback, according to the 2016 national American Academy of Pediatrics (AAP) guidelines on Sudden Unexplained Infant Death (SUID) risk factors, will be generated by the study team and communicated with parents.
Feedback will be given to parents in the intervention group at ages 1 and 2 months.
The control group parents will only receive this feedback at age 2 months.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months
大体时间：2 months of age
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Safe sleep environment will include:
|
2 months of age
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Parent compliance
大体时间：1 and 2 months of age
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Proportion of parents that send photographs of their infant's sleep environment at ages 1 month (intervention group) and 2 months (both groups)
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1 and 2 months of age
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ian M Paul, MD, MSc、Penn State Hershey Milton S Hershey Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- TASK FORCE ON SUDDEN INFANT DEATH SYNDROME. SIDS and Other Sleep-Related Infant Deaths: Updated 2016 Recommendations for a Safe Infant Sleeping Environment. Pediatrics. 2016 Nov;138(5):e20162938. doi: 10.1542/peds.2016-2938. Epub 2016 Oct 24.
- Canty EA, Fogel BN, Batra EK, Schaefer EW, Beiler JS, Paul IM. Improving infant sleep safety via electronic health record communication: a randomized controlled trial. BMC Pediatr. 2020 Oct 8;20(1):468. doi: 10.1186/s12887-020-02369-2. Erratum In: BMC Pediatr. 2020 Oct 24;20(1):493.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月30日
初级完成 (实际的)
2019年9月11日
研究完成 (实际的)
2019年9月11日
研究注册日期
首次提交
2018年9月5日
首先提交符合 QC 标准的
2018年9月5日
首次发布 (实际的)
2018年9月7日
研究记录更新
最后更新发布 (实际的)
2019年10月11日
上次提交的符合 QC 标准的更新
2019年10月9日
最后验证
2019年10月1日
更多信息
与本研究相关的术语
其他研究编号
- STUDY00010450
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
no plan to IPD with other researchers
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Safe的临床试验
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Cedars-Sinai Medical CenterHuntington Hospital; UniHealth Foundation; Ronald Reagan Medical Center; Torrance Memorial完全的体弱的老年人
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McGill University Health Centre/Research Institute...招聘中
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University of DenverNational Institute on Drug Abuse (NIDA)完全的
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Cedars-Sinai Medical CenterAgency for Healthcare Research and Quality (AHRQ)邀请报名