Safe Sleep Education App for Sudden Infant Death Syndrome

Overseen By Mary Beth Howard, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Non English speaking, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to teach safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS). The app, called Safety in Seconds, provides educational content on safe sleep techniques, such as using a firm mattress and avoiding soft bedding, while parents wait in pediatric emergency departments. Participants in the trial will receive information on either safe sleep or car seat safety through the app. English-speaking caregivers of infants aged 0-4 months who own a smartphone may be suitable for this trial. As an unphased trial, this study allows caregivers to contribute to important research that could enhance infant safety practices.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications.

What prior data suggests that this app is safe for delivering education on safe sleep practices?

Research has shown that the Safety in Seconds (SIS) mobile app, which includes safe sleep education, is well-founded. Initially focused on car seat and fire safety, the app has proven effective in similar educational areas. Studies have successfully integrated safe sleep education into the app, demonstrating improved parental knowledge about safe sleep practices.

The app teaches safe sleep habits, such as placing babies on their backs and using a firm sleep surface, to help prevent sudden infant deaths. These practices align with recommendations from the American Academy of Pediatrics. As the app educates rather than provides medication or physical treatments, it is considered safe for users. No reports of negative effects have emerged from its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safe Sleep Education app because it takes a fresh approach to tackling Sudden Infant Death Syndrome (SIDS) through digital education. Unlike traditional methods that might involve pamphlets or in-person sessions, this mobile app delivers safe sleep guidelines directly to parents' phones, making it more accessible and convenient. Additionally, with the app's ability to provide interactive and engaging content, it has the potential to improve user engagement and retention of critical safety information, potentially increasing adherence to safe sleep practices and reducing the risk of SIDS significantly.

What evidence suggests that the Safety in Seconds app is effective for safe sleep education?

Research has shown that following safe sleep practices can significantly lower the risk of Sudden Infant Death Syndrome (SIDS) and similar deaths. The American Academy of Pediatrics advises creating a safe sleep environment by placing babies on their backs, using a firm mattress, and keeping soft items out of the crib. In this trial, the Safety in Seconds mobile app will deliver safe sleep education to one group of participants. Past studies have demonstrated the app's success in teaching safety topics like car seat and fire safety. Now, this trial will test its effectiveness in providing safe sleep education, quickly sharing important information with parents, especially in busy pediatric emergency rooms. The app's success in other safety areas suggests it could be a helpful tool for teaching safe sleep practices. ^{1 3 4 6 7}

Who Is on the Research Team?

Mary Beth Howard, MD, MSc

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for parents or caregivers who use smartphones and visit pediatric emergency departments. It aims to educate them on safe sleep practices to prevent Sudden Infant Death Syndrome (SIDS) using a mobile app.

Inclusion Criteria

You have access to a smartphone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive safe sleep education via the Safety in Seconds mobile app

1 month

1 visit (in-person) for app setup and education

Follow-up

Participants are monitored for changes in safe sleep behaviors through surveys and interviews

1 month

Follow-up surveys and interviews

What Are the Treatments Tested in This Trial?

Interventions

• Safety in Seconds mobile app: Safe Sleep Education

Trial Overview The study tests the integration of safe sleep education into an existing m-Health app called Safety in Seconds, which already provides car seat safety education. The effectiveness of this enhanced app will be evaluated in the PED setting.

How Is the Trial Designed?

Group I: Safe Sleep Education Experimental Treatment 1 Intervention

The intervention group will receive safe sleep education via the Safety in Seconds mobile app.

Group II: Car seat safety Active Control 1 Intervention

The attention matched control group will receive car seat safety education via the Safety in Seconds mobile app.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

American SIDS Institute

Collaborator

Trials

4

Recruited

610+

Citations

1. withpower.com withpower.com/trial/phase-infant-death-3-2024-21464

Safe Sleep Education App for Sudden Infant Death ... ... Safety in Seconds mobile app: Safe Sleep Education will have tolerable side effects & efficacy for patients with Sudden Infant Death Syndrome and Sudden ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7681145/

Field assessment of a safe sleep instrument using ... Sudden unexpected infant death is the leading cause of infant mortality with black: white infant mortality remaining at 2:1 for the last decade.

3. pediatrics.jmir.org pediatrics.jmir.org/2025/1/e65247

Integrating Infant Safe Sleep and Breastfeeding Education Into ... Conclusions: Integrating safe sleep and breastfeeding education within a pregnancy app may allow for rapid dissemination of infant care ...

4. publications.aap.org publications.aap.org/pediatrics/article/150/1/e2022057991/188305/Evidence-Base-for-2022-Updated-Recommendations-for

Evidence Base for 2022 Updated Recommendations for a ... The American Academy of Pediatrics recommends a safe sleep environment to reduce the risk of all sleep-related deaths.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561672218000111

Sudden Infant Death Syndrome and Safe Sleep on Twitter The objective of our study was to investigate the social media conversation around SIDS and safe sleep to understand the possible influences and guide health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11748811/

Integrating Infant Safe Sleep and Breastfeeding Education ... Our data demonstrate that it is possible to embed safe sleep and breastfeeding education into an app designed to improve outcomes during ...

7. youtube.com youtube.com/watch?v=uqPLQ0FRLqg

Infant Safe Sleep: An Introduction and Model Program - May 8 ... SUID, the sudden and unexpected death of a baby less than 1 year old in which the cause was not obvious before investigation, includes sudden ...