Infant Safe Sleep Practices, SIDS
Conditions
Keywords
Safe Sleep, Pediatric Emergency Department
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.
Interventions
BEHAVIORALSafe Sleep Education
60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout
BEHAVIORALBehavior 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.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in proportion of infants who are fully adherent to 4 AAP safe sleep guidelines. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | The investigators will assess caregiver's knowledge of safe sleep practices before and after the educational intervention. |
| 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. | 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. |
| 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. | 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. |
| Caregiver Acceptability of the Self-Tracking Tool | 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. |
| Differences in Intervention Effectiveness Across Caregiver and Infant Demographic Characteristics | 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. |
| Association Between Safe Sleep Practices and Caregiver-Reported Infant Sleep Quality | 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. |
| Association Between Safe Sleep Practices and Infant Sleep Onset Latency | 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. |
Countries
United States
Outcome results
None listed