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Smart bassinet under watch: can it keep High-Risk infants safe?

NCT ID NCT06361303

Knowledge-focused Sponsor: Happiest Baby, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Updated 1 time

Summary

This study follows 1,000 caregivers and their high-risk infants who use the SNOO Smart Sleeper Bassinet at home. Researchers will track any serious injuries or deaths linked to the device to see how safe it really is. The goal is to gather real-world safety data for babies at higher risk of sudden unexpected death.

What this could mean

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

What this could lead to
If successful, this study could confirm that the SNOO bassinet is safe for high-risk infants, potentially reducing fear and uncertainty for parents.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Rare safety issues may still go undetected due to the limited sample size.

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.

Participants

About 1,000 people

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

Started

Nov 2023

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Caregivers of infants who use SNOO and are at high risk of SUID, as determined by our eligibility criteria. No more than 25% of enrolled subjects will consist of infant users who exclusively used SNOO from birth to 1 month of age. The majority of enrolled subjects (\>50%) will have engaged in SNOO use at some point between 1 and 4 months of infant age. If these enrollment targets are not met, additional subjects will be enrolled until the proposed age distribution and usage criteria are met.

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: Infant/caregiver dyads meeting the following inclusion criteria will be eligible for study enrollment: * Respondent must identify as a primary caregiver of the infant. * Purchase or rental of SNOO shipped to a U.S. residence during the defined enrollment period. * Caregivers must be English speakers ages 18 or older residing in the United States. * Infants must use SNOO during the intended use period (i.e., birth to 6 months). * Infants must meet at least one of the following criteria for high risk for SUID: * Infant race: Black or African American; and/or American Indian or Alaskan Native * Maternal education: 12 years or less * Low birth weight: \<5 pounds 8 ounces (\<2500 grams) * Last menstrual cycle (LMP) or obstetrical estimate (OE) Gestational age at time of birth: \<37 weeks (preterm) * Maternal age at time of birth: \<25 years * Smoking status: Any self-reported maternal smoking during pregnancy Exclusion Criteria: * Not primary caregiver * Does not speak English * Is not a US resident * Is not 18 years old or older * Infant did not use SNOO during the intended use period (i.e., birth to 6 months). * Infants does NOT meet at least one of the below risk criteria: * Infant race: Black or African American; and/or American Indian or Alaskan Native * Maternal education: 12 years or less * Low birth weight: \<5 pounds 8 ounces (\<2500 grams) * LMP or OE Gestational age at time of birth: \<37 weeks (preterm) * Maternal age at time of birth: \<25 years * Smoking status: Any self-reported maternal smoking during pregnancy

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Conditions

The condition(s) this trial relates to.

Infant Death injury sudden unexpected infant death prevention target

As listed by the trial registrant

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

Infant death Serious injury

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

  • Happiest Baby, Inc.

    RECRUITING

    Los Angeles, California, 90064, United States

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