Infant Safe Sleep in Pediatric Emergency Depratment

NCT07779512 | Not Yet Recruiting

• 1 other identifier: STUDY00010663
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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

Keywords

Safe Sleep; Pediatric Emergency Department

Outcome Measures

Primary Outcomes (1)

• Change in proportion of infants who are fully adherent to 4 AAP safe sleep guidelines.

  The investigators will assess whether providing a brief, evidence-based safe-sleep education video alone versus an evidence-based safe-sleep education video plus habit tracking increases full adherence to 4 pre-determined AAP safe sleep guideline recommended behaviors among caregivers of infants 0-4 months.

  Will be evaluated at 2 and 4 weeks after initial emergency department visit / intervention time.

Secondary Outcomes (10)

• Change in proportion of infants who are fully adherent to each individual AAP safe sleep guideline.

  Will be evaluated at 2 weeks and 4 weeks following initial emergency department visit and intervention.

• Evaluate the change in caregiver safe sleep knowledge score before and after the educational intervention.

  This will occur at the initial emergency department visit, as well as the 2 and 4 week follow-ups.

• Change in Reported Infant Sleep Duration Before and After the Intervention

  This will occur at the initial emergency department visit, 2 and 4 week follow-ups.

• Association Between Safe Sleep Practices and Number of Nighttime Infant Awakenings

  Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.

• Caregiver Acceptability of the Self-Tracking Tool

  Assessed at the end of the emergency department intervention portion of the study.

Study Arms (2)

Safe Sleep Education

ACTIVE COMPARATOR

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.

Behavioral: Safe Sleep Education

Behavior Habit Tracking Plus Safe Sleep Education

EXPERIMENTAL

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.

Behavioral: Safe Sleep Education; Behavioral: Behavior habit tracking

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 Plus Safe Sleep Education; Safe Sleep Education

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.

Behavior Habit Tracking Plus Safe Sleep Education

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Golisano Children's Hospital of Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (6)

• Kappy B, Edmunds K, Frey M, Zhang Y, Boyd S, Looman K, Pomerantz WJ, Hanke S, Kerrey B. Emergency Department Visits Before Sudden Unexpected Infant Death: A Touchpoint for Unsafe Sleep Reduction. Acad Pediatr. 2022 Aug;22(6):1065-1072. doi: 10.1016/j.acap.2022.03.009. Epub 2022 Mar 18.

  PMID: 35307602 BACKGROUND

• Howard MB, Ryan LM, Psoter KJ, Solomon BS, Mutala M, Ehrenberg S, Moon R. Changes in Sleep Practices During and After Illness. Pediatrics. 2025 Oct 1;156(4):e2025071605. doi: 10.1542/peds.2025-071605.

  PMID: 40962332 BACKGROUND

• Willmott TJ, Pang B, Rundle-Thiele S. Capability, opportunity, and motivation: an across contexts empirical examination of the COM-B model. BMC Public Health. 2021 May 29;21(1):1014. doi: 10.1186/s12889-021-11019-w.

  PMID: 34051788 BACKGROUND

• Whiteside-Mansell L, Nabaweesi R, Caballero AR, Mullins SH, Miller BK, Aitken ME. Assessment of Safe Sleep: Validation of the Parent Newborn Sleep Safety Survey. J Pediatr Nurs. 2017 Jul-Aug;35:30-35. doi: 10.1016/j.pedn.2017.02.033. Epub 2017 Mar 8.

  PMID: 28728766 BACKGROUND

• Edmondson C, Shenoy RD, Herrera JH, Williams K, Acuna JM. Maternal adherence to safe infant sleep recommendations in the USA: trends and disparities from PRAMS 2016-2022. BMJ Paediatr Open. 2026 Mar 12;10(1):e004382. doi: 10.1136/bmjpo-2025-004382.

  PMID: 41819564 BACKGROUND

• Walsh P, Vieth T, Rodriguez C, Lona N, Molina R, Habebo E, Caldera E, Garcia C, Veazey G. Using a pacifier to decrease sudden infant death syndrome: an emergency department educational intervention. PeerJ. 2014 Mar 13;2:e309. doi: 10.7717/peerj.309. eCollection 2014.

  PMID: 24688883 BACKGROUND

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 21, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)