An interventional study of Safe Sleep Education and Behavior habit tracking in Infant Safe Sleep Practices and SIDS, sponsored by State University of New York at Buffalo. Recruiting at 1 site in United States. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Other
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.
80 studies on the registry are indexed under Sudden Infant Death; 14 are open to participants now.
This study's planned enrollment of 214 is above the median of 60 across 51 interventional studies indexed under Sudden Infant Death.
Browse Sudden Infant Death studies →State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout
A daily sleep behavior tracking form over 4 weeks will be provided along with information about how tracking behaviors can form healthy habits.
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.
Time frame: Will be evaluated at 2 and 4 weeks after initial emergency department visit / intervention time.
Change in proportion of infants who are fully adherent to each individual AAP safe sleep guideline.
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.
Time frame: 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.
The investigators will assess caregiver's knowledge of safe sleep practices 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.
Change in Reported Infant Sleep Duration Before and After the Intervention
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.
Time frame: 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
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.
Time frame: Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.
Caregiver Acceptability of the Self-Tracking Tool
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.
Time frame: Assessed at the end of the emergency department intervention portion of the study.
Differences in Intervention Effectiveness Across Caregiver and Infant Demographic Characteristics
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.
Time frame: Demographic and clinical characteristics will be collected at enrollment, and intervention effectiveness will be assessed through the 4-week follow-up.
Change in Reported Infant Sleep Duration Before and After the Intervention
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.
Time frame: Assessed at the initial emergency department visit (baseline), 2-week follow-up, and 4-week follow-up.
Change in Reported Infant Sleep Duration Before and After the Intervention
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.
Time frame: Assessed at the initial emergency department visit (baseline), 2-week follow-up, and 4-week follow-up.
Association Between Safe Sleep Practices and Caregiver-Reported Infant Sleep Quality
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.
Time frame: Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.
Association Between Safe Sleep Practices and Infant Sleep Onset Latency
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.
Time frame: Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.
Plan to share: No — The study involves collection of individual-level data from caregivers and infants, and participant privacy and confidentiality will be maintained in accordance with the IRB-approved study protocol and informed consent process. Deidentified aggregate results will be reported in publications and presentations.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 11 months after the start.
Of 15 interventional studies with no phase under Sudden Infant Death, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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