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

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Conditions

  • Infant Safe Sleep Practices
  • SIDS

Eligibility Criteria

Sex
ALL
Age
N/A - 3 Months
Healthy Volunteers
Not accepted

Interventions

  • Safe Sleep Education — BEHAVIORAL
    60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout
  • Behavior habit tracking — BEHAVIORAL
    A 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 Education
    Families 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 Education
    Families 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)

FacilityCityStateZIPSite coordinators
Golisano Children's Hospital of BuffaloBuffaloNew York14203
Sarah Ehrenberg, MD
716-323-0055

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