NCT06074211 Incorporation of Safe Sleep Education Into m-Health Technology
| NCT ID | NCT06074211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Sudden Infant Death |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-07-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sudden Unexplained Infant Death (SUID) is the leading cause of death in infants age 28 days to 1 year. Protective factors, such as supine positioning, firm sleep surface, breastfeeding, pacifier use, elimination of soft objects from the sleep space, and avoidance of tobacco, alcohol, and illicit drugs have been shown to decrease the risk. The American Academy of Pediatrics recommends that healthcare providers model and convey safe sleep practices during patient encounters. Pediatric emergency departments (PED) serve as front-line contact for populations at greatest risk for SUID, however few interventions have been tested in the PED setting. M- Health (mobile health) apps have previously demonstrated the ability to deliver safety education to parents and are well suited for use in the PED given limited clinician time and long wait times. Safety in Seconds (SIS) is a theory based, m-Health injury prevention tool focused on care seat safety and fire safety with previously demonstrated effectiveness in an NIH-funded randomized trial. This study aims to add safe sleep education into the SIS, and subsequently disseminate the app in the PED setting. Integration of safe sleep education into SIS represents an opportunity to increase safe sleep knowledge and practices through a proven effective m-Health intervention. This study addresses this potential by incorporating a previously developed, theory-driven and evidence-based safe sleep education into the SIS app and testing the feasibility of deployment in the PED.
Eligibility Criteria
Inclusion Criteria: * English speaking caregivers over 18 of infants age 0-4 months * Use a smart phone Exclusion Criteria: * Non English speaking * Under 18 years of age or unable to consent for themselves * High acuity, critical care needs of infant patient that would limit participation during initial PED visit.
Contact & Investigator
Mary Beth Howard, MD, MSc
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06074211 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sudden Infant Death. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06074211 currently recruiting?
Yes, NCT06074211 is actively recruiting participants. Contact the research team at mhowar50@jh.edu for enrollment information.
Where is the NCT06074211 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06074211 clinical trial?
NCT06074211 is sponsored by Johns Hopkins University. The principal investigator is Mary Beth Howard, MD, MSc at Johns Hopkins School of Medicine. The trial plans to enroll 150 participants.