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Incorporation of Safe Sleep Education Into m-Health Technology
NCT06074211 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Safety in Seconds mobile app: Safe Sleep Education
- BEHAVIORAL Safety in Seconds mobile app: Car Seat Safety Education
Study Locations (1)
Maryland
- Johns Hopkins School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2027-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06074211
The ClinicalTrials.gov registry entry for NCT06074211 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sudden Infant Death appearing as the primary indexed condition, and to 2 interventions — of which Safety in Seconds mobile app: Safe Sleep Education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06074211 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06074211 about?
NCT06074211 is a clinical study titled "Incorporation of Safe Sleep Education Into m-Health Technology". 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 dru...
What is the current status of trial NCT06074211?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2025-07-01. Estimated completion is 2027-04.
What conditions does trial NCT06074211 study?
This clinical trial studies the following conditions: Sudden Infant Death. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06074211?
The interventions under investigation include: Safety in Seconds mobile app: Safe Sleep Education (BEHAVIORAL), Safety in Seconds mobile app: Car Seat Safety Education (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06074211?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06074211 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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