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Could a smartphone app help prevent sudden infant death?

NCT ID NCT06074211

Prevention Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests whether a mobile app called Safety in Seconds can effectively teach parents of infants about safe sleep practices to reduce the risk of Sudden Unexpected Infant Death (SUID). The app delivers educational modules on safe sleep, such as placing babies on their backs and using a firm sleep surface. Researchers are enrolling English-speaking caregivers of infants aged 0-4 months in a pediatric emergency department to see if the app improves safe sleep knowledge and behaviors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Safety in Seconds mobile app with safe sleep education module
What this could lead to
If effective, this mobile app could help reduce the risk of sudden infant death by teaching parents safe sleep practices during emergency department visits.
What could go wrong
This is a small feasibility study, so results may not apply broadly. The app's impact on actual sleep behaviors and SIDS rates remains unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Sudden Infant Death sudden unexpected infant death prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sudden infant death

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

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