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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention at 1 month + usual care | Active Comparator | Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months. |
|
| usual care | Placebo Comparator | Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe | Behavioral | 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. |
| 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:
| 2 months of age |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian M Paul, MD, MSc | Penn State Hershey Milton S Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27940804 | Background | 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. | |
| 33032546 | Derived | 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. |
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no plan to IPD with other researchers
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| ID | Term |
|---|---|
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073938 | Risk Evaluation and Mitigation |
| ID | Term |
|---|---|
| D012308 | Risk Management |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D018570 | Risk Assessment |
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2 month photographs will be evaluated by study team members blinded to the study group.
|
| D066088 |
| Infant Death |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |