Sudden Infant Death Syndrome (SIDS) Clinical Trials

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Development and Incorporation of Safe Sleep Education Into m-Health Technology for the Pediatric Emergency Department

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• English speaking caregivers over 18 of infants age 0-4 months

• Use a smart phone

Locations
United States
Maryland
Johns Hopkins School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
Mary Beth Howard, MD, MSc
mhowar50@jh.edu
443-287-7207
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-05
Participants
Target number of participants: 150
Treatments
Experimental: Safe Sleep Education
The intervention group will receive safe sleep education via the Safety in Seconds mobile app.
Active_comparator: Car seat safety
The attention matched control group will receive car seat safety education via the Safety in Seconds mobile app.
Related Therapeutic Areas
Sponsors
Collaborators: American SIDS Institute
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov