SNOO Bassinet for Sudden Infant Death Syndrome
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.12345Why 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?
Christopher Laine, PhD
Principal Investigator
Happiest Baby, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monitoring
Participants use the SNOO Bassinet and report any adverse events
Follow-up
Participants complete a follow-up survey to report outcomes and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- SNOO Bassinet
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria
Find a Clinic Near You
Who Is Running the Clinical Trial?
Happiest Baby, Inc.
Lead Sponsor
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. ...
6.
happiestbaby.com
happiestbaby.com/pages/snoo-safety-and-security?srsltid=AfmBOop3pQipQp0YJRddeYGJ2mLs44ILVSWqKpvR1nvi9UqmubgFsSvlSNOO 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 ...
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