Clinical trial NCT03662048: Improving Infant Sleep Safety With the Electronic Health Record
Official title: Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SIDS
Infant Development
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 130
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months
timeFrame: 2 months of age
Secondary outcomes:
measure: Parent compliance
timeFrame: 1 and 2 months of age
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Hershey Milton S Hershey Medical Center
name: Ian M Paul, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.