Improving Infant Sleep Safety With the Electronic Health Record

N/ACompletedNCT03662048

Milton S. Hershey Medical Center130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

130

Conditions

SIDS Infant Development

Interventions

SafeBEHAVIORAL

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.

Eligibility

Sex: ALLMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months

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

Time frame: 2 months of age

Secondary Outcomes

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)

Time frame: 1 and 2 months of age

Data from ClinicalTrials.gov

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