Infant Safe Sleep PracticesNCT07779512
Infant Safe Sleep in Pediatric Emergency Depratment
A study testing Safe Sleep Education and Behavior habit tracking in people with Infant Safe Sleep Practices and SIDS, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Infant Safe Sleep Practices, SIDS
- What is being tested?
- Safe Sleep Education and Behavior habit tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Golisano Children's Hospital of Buffalo
Buffalo, New York, 14203
Sarah Ehrenberg, MD, 716-323-0055, sarahehr@buffalo.edu
About this study
Official title: A Pediatric Emergency Department-based Intervention to Increase Infant Adherence to Safe Sleep Practices
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
- Being tested
- Safe Sleep Education, Behavior habit tracking
- Keywords
- Safe Sleep, Pediatric Emergency Department
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Sleep EducationBehavioural
60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout
Behavior habit trackingBehavioural
A daily sleep behavior tracking form over 4 weeks will be provided along with information about how tracking behaviors can form healthy habits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Safe Sleep Education; Behavioral: Behavior habit tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start17 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infant Safe Sleep PracticesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Anne Ehrenberg, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779512
- Sponsor's protocol ID
- STUDY00010663
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 35307602Howard 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.
PubMed 40962332Willmott 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.
PubMed 34051788Whiteside-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.
PubMed 28728766Edmondson 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.
PubMed 41819564Walsh 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.
PubMed 24688883
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pediatric Emergency Department-based Intervention to Increase Infant Adherence to Safe Sleep Practices
- ClinicalTrials.gov ID
- NCT07779512
- Acronym / sponsor ID
- STUDY00010663
- Conditions
- Infant Safe Sleep Practices, SIDS
- Keywords
- Safe Sleep, Pediatric Emergency Department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe Sleep Education | Active comparator | Behavioral: Safe Sleep EducationFamilies 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. |
| Behavior Habit Tracking Plus Safe Sleep Education | Experimental | Behavioral: Safe Sleep Education, Behavioral: Behavior habit trackingFamilies 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. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Sleep Education60 second safe sleep educational video from the NIH (https://www.youtube.com/watch?v=Rs9Jw3uIoaU) with associated infant safe sleep handout | Behavioural | Behavior Habit Tracking Plus Safe Sleep Education, Safe Sleep Education |
| Behavior habit trackingA daily sleep behavior tracking form over 4 weeks will be provided along with information about how tracking behaviors can form healthy habits. | Behavioural | Behavior Habit Tracking Plus Safe Sleep Education |
Primary outcome
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.
10 secondary outcomes
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.
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.
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.
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.
Caregiver 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
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
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
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
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
Time frame: Assessed at the initial emergency department visit, 2-week follow-up, and 4-week follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 35307602Kappy 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.
- Background: PubMed 40962332Howard 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.
- Background: PubMed 34051788Willmott 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.
- Background: PubMed 28728766Whiteside-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.
- Background: PubMed 41819564Edmondson 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.
- Background: PubMed 24688883Walsh 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Sleep Education and Behavior habit tracking in people with Infant Safe Sleep Practices and SIDS, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07779512, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.