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NCT Number: NCT07779512

Infant Safe Sleep in Pediatric Emergency Depratment

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.

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Key information

Conditions

Infant Safe Sleep Practices Death Death, Sudden Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms SIDS Sudden Infant Death

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golisano Children's Hospital of Buffalo

Buffalo, New York, 14203, United States

Location contact

Sarah Ehrenberg, MD

CONTACT

[email protected]

716-323-0055

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

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

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

    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 each of the 4 pre-determined AAP safe sleep guidelines recommended behaviors among caregivers of infants 0-4 months.

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

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

    The investigators will assess caregiver's knowledge of safe sleep practices before and after the educational intervention.

  3. Change in Reported Infant Sleep Duration Before and After the Intervention

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

    The investigators will assess the change in caregiver-reported average total infant sleep duration over a 24-hour period before and after the intervention.

    Unit of Measure: Mean hours of infant sleep per 24-hour period.

    Measurement Tool: Caregiver-reported infant sleep characteristics questionnaire administered as part of the study survey.

  4. Association Between Safe Sleep Practices and Number of Nighttime Infant Awakenings

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

    The investigators will assess the association between adherence to recommended safe sleep practices and caregiver-reported infant nighttime awakenings.

    Unit of Measure: Difference in mean number of nighttime awakenings per night according to safe sleep practice adherence status.

    Measurement Tool: Safe sleep behavior questionnaire and caregiver-reported infant sleep characteristics questionnaire.

  5. Caregiver Acceptability of the Self-Tracking Tool

    Time frame: Assessed at the end of the emergency department intervention portion of the study.

    The investigators will assess caregiver-reported acceptability and perceived usefulness of the self-tracking tool provided to participants in the intervention group.

    Unit of Measure: Mean score on a 5-point Likert scale, with higher scores indicating greater acceptability.

    Measurement Tool: Study-specific caregiver acceptability questionnaire assessing perceived usefulness, ease of use, and overall acceptability of the self-tracking tool.

  6. Differences in Intervention Effectiveness Across Caregiver and Infant Demographic Characteristics

    Time frame: Demographic and clinical characteristics will be collected at enrollment, and intervention effectiveness will be assessed through the 4-week follow-up.

    The investigators will assess whether the effectiveness of the intervention on adherence to recommended safe sleep practices differs according to selected caregiver and infant demographic characteristics. Characteristics examined will include caregiver age, caregiver education level, number of children, infant prematurity, and previous receipt of safe sleep educaction

    Unit of Measure: Difference in the proportion of infants adherent to recommended safe sleep practices between the intervention and control groups within demographic subgroups.

    Measurement Tool: Safe sleep behavior questionnaire and caregiver demographic questionnaire; infant prematurity and other relevant clinical characteristics will be obtained from the electronic medical record when available.

  7. Change in Reported Infant Sleep Duration Before and After the Intervention

    Time frame: Assessed at the initial emergency department visit (baseline), 2-week follow-up, and 4-week follow-up.

    The investigators will assess the change in the caregiver-reported average number of times the infant wakes during the night before and after the intervention.

    Unit of Measure: Mean number of nighttime awakenings per night.

    Measurement Tool: Caregiver-reported infant sleep characteristics questionnaire administered as part of the study survey.

  8. Change in Reported Infant Sleep Duration Before and After the Intervention

    Time frame: Assessed at the initial emergency department visit (baseline), 2-week follow-up, and 4-week follow-up.

    The investigators will assess the change in caregiver perception of how well their infant sleeps before and after the intervention.

    Unit of Measure: Mean score on a 5-point Likert scale, with higher scores indicating better perceived infant sleep quality.

    Measurement Tool: Caregiver-reported infant sleep characteristics questionnaire administered as part of the study survey.

  9. Association Between Safe Sleep Practices and Caregiver-Reported Infant Sleep Quality

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

    The investigators will assess the association between adherence to recommended safe sleep practices and caregiver perception of how well their infant sleeps.

    Unit of Measure: Difference in mean caregiver-reported infant sleep quality score on a 5-point Likert scale according to safe sleep practice adherence status.

    Measurement Tool: Safe sleep behavior questionnaire and caregiver-reported infant sleep characteristics questionnaire.

  10. Association Between Safe Sleep Practices and Infant Sleep Onset Latency

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

    The investigators will assess the association between adherence to recommended safe sleep practices and the caregiver-reported amount of time required for the infant to fall asleep.

    Unit of Measure: Mean minutes required for the infant to fall asleep.

    Measurement Tool: Safe sleep behavior questionnaire and caregiver-reported infant sleep characteristics questionnaire.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

A Pediatric Emergency Department-based Intervention to Increase Infant Adherence to Safe Sleep Practices

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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