Improving Infant Sleep Safety With the Electronic Health Record

Penn State Health

Status: Completed

Conditions: SIDS; Infant Development

Treatments: Behavioral: Safe

Study type: Interventional

Funder types: Other

Identifiers

NCT03662048

STUDY00010450

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups, including a placebo group

intervention at 1 month + usual care

Active Comparator group

Description:

Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months.

Treatment:

Behavioral: Safe

usual care

Placebo Comparator group

Description:

Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months.

Treatment:

Behavioral: Safe