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New app aims to prevent sudden infant death by improving Doctor-Parent chats

NCT ID NCT05503771

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study tests whether a new digital tool can help doctors talk to parents about safe sleep for babies. The tool includes a questionnaire for parents and a smart form for doctors, plus training in motivational interviewing. Researchers will enroll 350 parents and their infants at a pediatric clinic, comparing those whose doctors use the tool to those receiving standard care. The goal is to see if the tool improves how doctors counsel parents and leads to safer sleep practices, potentially reducing the risk of sudden infant death.

What this could mean

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

Active substance
Infant Sleep Assessment (ISA) tool with motivational interviewing training
What this could lead to
If successful, this could lead to better doctor-parent conversations about safe sleep and lower rates of sleep-related infant deaths.
What could go wrong
This is a small, early-stage behavioral study (350 participants) focused on communication, not a direct medical intervention. Results may not apply to all clinics or populations.

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 350 people

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

Started

Sep 2022

Expected to finish

Feb 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

3 days to 75 years

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 and Spanish-speaking parents and legal guardians bringing their infants to the Harriet Lane Clinic (pediatric primary care clinic) for any of their early well baby visits (between 3-5 days up to 4 weeks of age) * Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate. Exclusion Criteria: * Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.) * Assigned resident is not enrolled in the study

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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 Sudden unexplained 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

  • Harriet Lane Clinic

    RECRUITING

    Baltimore, Maryland, 21287, United States

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