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NCT06074211 · ClinicalTrials.gov registry record · NA
Incorporation of Safe Sleep Education Into m-Health Technology
A NA study of Sudden Infant Death, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06074211: Active NA study of Sudden Infant Death, sponsored by Johns Hopkins University.
NCT06074211 is a NA study of Sudden Infant Death that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06074211, a NA study of Sudden Infant Death, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Safe sleep behaviors will be measured by the number of participants who adapt safe sleep behaviors.
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 |
What the registry record for NCT06074211 still lists
NCT06074211 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
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.
NCT06074211 reports a single indexed study location in Maryland.
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.
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).
Who is sponsoring clinical trial NCT06074211?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06074211's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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