1000 Participants Needed

SNOO Bassinet for Sudden Infant Death Syndrome

CL
SC
NG
Overseen ByNichole Gogatz
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Happiest Baby, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety of the SNOO Smart Sleeper Bassinet for babies at high risk for Sudden Unexpected Infant Death (SUID). Researchers aim to determine the frequency of serious injuries or deaths when infants use this bassinet. Caregivers in the U.S. who use the SNOO for infants born preterm, with low birth weight, or whose mothers had conditions such as smoking during pregnancy, are eligible to participate. As an unphased trial, this study allows caregivers to contribute to important safety research for infants.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on the use of the SNOO Bassinet for infants, so it's unlikely that your medications would be affected.

What is the safety track record for the SNOO Smart Sleeper Bassinet?

Research has shown that the SNOO Smart Sleeper Bassinet prioritizes safety. It meets safety standards and has received FDA approval. The bassinet keeps babies on their backs, reducing the risk of Sudden Infant Death Syndrome (SIDS) and Sudden Unexpected Infant Death (SUID). Additionally, no data breaches have been reported with the SNOO.

The SNOO employs a safe swaddling method that secures the baby without placing them on their stomach, enhancing sleep safety. This is crucial for babies who cannot yet roll over on their own.

While the study aims to gather more information on safety outcomes such as death or serious injury, current evidence supports the SNOO's role in promoting safe sleep for infants.12345

Why are researchers excited about this trial?

Researchers are excited about the SNOO Bassinet because it offers a unique approach to infant sleep and safety compared to traditional cribs and bassinets. Unlike standard options, the SNOO uses gentle rocking motions and soothing sounds to help infants sleep better and potentially reduce the risk of sleep-related issues. Additionally, it features a built-in swaddle system that keeps babies secure on their backs, which is known to lower the risk of Sudden Infant Death Syndrome (SIDS). These innovative features make the SNOO a promising tool for enhancing infant sleep quality and safety, sparking interest among caregivers and healthcare professionals.

What evidence suggests that the SNOO Bassinet is effective for preventing SUID?

Research has shown that the SNOO Smart Sleeper Bassinet can improve sleep for babies and parents. Studies have found that it calms fussy babies and reduces crying, similar to parental soothing. Some reports suggest that babies may sleep more peacefully and show better health signs when using the SNOO. This bassinet mimics the comforting sensations of the womb and safely swaddles babies, contributing to its effectiveness. However, it's important to note that while these results are encouraging, the data remains somewhat limited.45678

Who Is on the Research Team?

CL

Christopher Laine, PhD

Principal Investigator

Happiest Baby, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I was born weighing less than 5 pounds 8 ounces.
I was under 25 years old when I gave birth.
My infant will use the SNOO from birth to 6 months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month
Electronic survey

Monitoring

Participants use the SNOO Bassinet and report any adverse events

6 months
Electronic survey

Follow-up

Participants complete a follow-up survey to report outcomes and adverse events

1 month
Electronic survey

What Are the Treatments Tested in This Trial?

Interventions

  • SNOO Bassinet

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SNOO usersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Happiest Baby, Inc.

Lead Sponsor

Trials
3
Recruited
1,200+

Citations

The five “S's” and the “SNOO” Smart Sleeper—non ... - PMC

The results are promising: babies and parents sleep meaningfully better and crying also decreases significantly. 'Parents are often so satisfied with the crib, ...

A descriptive evaluation of time savings and work ...

SNOO has been found to be equally effective at eliciting a calming response in infants when compared to parent soothing (Möller et al., 2019). An analysis of ...

Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments. Detailed Description. Sleep plays ...

Research

SNOO Smart Sleeper is a responsive bassinet that calms fussy infants and improves sleep using womb-like sensations and safe swaddling that secures babies in ...

Do I Need a SNOO?

The SNOO is a robot bassinet for improving sleep, but it's expensive. It may help, but it's not for everyone, and there are limited data. ...

SNOO Safety and Security

SNOO meets safety standards, keeps babies on their back, is FDA authorized, has security measures, and has never had a data breach.

The Happiest Baby, Inc. SNOO Postmarket Surveillance ...

This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet. Detailed ...

SNO0 SMART SLEEPER - accessdata.fda.gov

An infant supine sleep system facilitates a supine position during sleep for infants who cannot roll over, reducing SIDS/SUID risk. The SNO0 ...