Recruiting

Safe Sleep Tracking

Sponsor:

State University of New York at Buffalo

Code:

NCT07779512

Conditions

Infant Safe Sleep Practices

SIDS

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Safe Sleep Education

Behavior habit tracking

Study Details

Brief summary:

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.

Conditions

Infant Safe Sleep Practices

SIDS

Study ID

NCT07779512

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Legal guardian of infants ages 0 to < 4 months , evaluated in GCHB PED ages 0 to < 4 months
  • English speaking primary caregiver of infant
  • Infant ED triaged ESI 2-5
  • Able to complete follow-up surveys via phone or email
  • Family not completely adherent to all 4 pre-determined safe sleep guideline recommended behaviors. If they are adherent to 3 out of 4 guidelines, they are eligible for the study.

Exclusion Criteria:

  • Infants requiring intensive interventions where PED education is not feasible
  • Non-English-speaking primary caregiver
  • Legal guardian unable to complete baseline survey or provide follow-up contact
  • Legal guardian completely adherent to safe sleep guidelines

Study Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Safe Sleep Education

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

A daily sleep behavior tracking form over 4 weeks will be provided along with information about how tracking behaviors can form healthy habits.

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. ]

Central Contacts and Locations

Locations

Golisano Children's Hospital of Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Sarah Ehrenberg, MD

716-323-0055sarahehr@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Nov 4, 2026

Last verified

Aug, 2026

Keywords

  • Safe Sleep
  • Pediatric Emergency Department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.