Improving Infant Sleep Safety With the Electronic Health Record

Infant Development Clinical Trial

Official title:

Improving Infant Sleep Safety With the Electronic Health Record: Using Infant Photographs Taken by Parents for Individualized Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662048
• Other study ID #: STUDY00010450
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: September 11, 2019

Study information

• Verified date: October 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Development
• SIDS

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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). pii: e20162938. Epub 2016 Oct 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months	Safe sleep environment will include: Solitary vs. non-solitary sleep; Supine vs. non-supine infant sleep position; No loose objects vs. loose objects on the sleep surface; Tight-bedding vs. loose-bedding; Firm vs. soft sleep surface (i.e. crib/bassinete vs. sofa/bouncy chair); Infant's sleeping in same room as parents vs. separate room; No head coverings vs. head coverings	2 months of age
Secondary	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