Improving Infant Sleep Safety With the Electronic Health Record

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2019-09-11

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).

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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.

Conditions

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SIDS Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

2 month photographs will be evaluated by study team members blinded to the study group.

Study Groups

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intervention at 1 month + usual care

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

Group Type ACTIVE_COMPARATOR

Safe

Intervention Type 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.

usual care

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

Group Type PLACEBO_COMPARATOR

Safe

Intervention Type 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.

Interventions

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Safe

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.

Intervention Type BEHAVIORAL

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

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ian M. Paul, MD

Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Faculty Affairs, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR