Improving Infant Sleep Safety With the Electronic Health Record

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback

Conditions
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SIDS, Infant Development

Intervention / Treatment
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* Behavioral: Safe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention at 1 month + usual care<br>Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months. | Behavioral: Safe<br>* 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.<br>|
| Placebo Comparator: usual care<br>Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months. | Behavioral: Safe<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months | Safe sleep environment will include: Solitary vs. non-solitary sleep Supine vs. non-supine infant sleep position No loose objects vs. loose objects on the sleep surface Tight-bedding vs. loose-bedding Firm vs. soft sleep surface (i.e. crib/bassinete vs. sofa/bouncy chair) Infant's sleeping in same room as parents vs. separate room No head coverings vs. head coverings | 2 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent compliance | Proportion of parents that send photographs of their infant's sleep environment at ages 1 month (intervention group) and 2 months (both groups) | 1 and 2 months of age |