Infant Safe Sleep in Pediatric Emergency Depratment
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- State University of New York at Buffalo
- Study ID
- NCT07779512
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Infant Safe Sleep Practices
- SIDS
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 3 Months
- Healthy Volunteers
- Not accepted
Interventions
- Safe Sleep Education — BEHAVIORAL60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout
- Behavior habit tracking — BEHAVIORALA daily sleep behavior tracking form over 4 weeks will be provided along with information about how tracking behaviors can form healthy habits.
Study Details
Safe sleep recommendations from the American Academy of Pediatrics (AAP) are designed to reduce the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths. These recommendations include placing infants on their backs to sleep, using a crib or bassinet, avoiding soft bedding, and not sharing a sleep space with other people. Many families do not consistently follow all recommended safe sleep practices, particularly when infants are sick. Research has shown that educational programs provided in pediatric emergency departments can improve some safe sleep behaviors, but improvements have been limited and may not continue over time. Additional strategies are needed to help families adopt and maintain safe sleep practices. The purpose of this study is to determine whether a daily safe sleep tracking tool, used together with brief safe sleep education, can improve caregivers' adherence to recommended safe sleep practices compared with education alone. The information learned from this study may help healthcare providers develop more effective ways to promote safe sleep and reduce the risk of sleep-related infant deaths.
Key Dates
- First listed
- Aug 21, 2026
- Start date
- Aug 17, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 1, 2027
- Completion
- Sep 1, 2027
Study Design
- Enrollment
- 214 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Active Comparator: Safe Sleep EducationFamilies will watch a brief (1 minute) educational video on safe sleep in the pediatric emergency department and then receive a handout summarized infant safe sleep practices.
- Experimental: Behavior Habit Tracking Plus Safe Sleep EducationFamilies will watch a brief (1 minute) educational video on safe sleep in the pediatric emergency department and then receive a handout summarized infant safe sleep practices. After this, they will receive brief information on habit tracking for behavioral change and a form to take home to track their infant's sleep behaviors.
Primary Outcome Measure
Change in proportion of infants who are fully adherent to 4 AAP safe sleep guidelines. [ Time Frame: Will be evaluated at 2 and 4 weeks after initial emergency department visit / intervention time. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Golisano Children's Hospital of Buffalo | Buffalo | New York | 14203 |