Infant Safe Sleep in Pediatric Emergency Depratment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 3
SponsorState University of New York at Buffalo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Safe Sleep Education
Behavioral60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout
Behavior habit tracking
BehavioralA daily sleep behavior tracking form over 4 weeks will be provided along with information about how tracking behaviors can form healthy habits.
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: Safe Sleep EducationActive comparator 1 intervention
Group B: Behavior Habit Tracking Plus Safe Sleep EducationExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Will be evaluated at 2 and 4 weeks after initial emergency department visit / intervention time.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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