Actively Recruiting
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Led by Happiest Baby, Inc. · Updated on 2025-09-05
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of the Happiest Baby, Inc. SNOO Smart Sleeper Bassinet for infants at high risk of Sudden Unexpected Infant Death (SUID). The study involves surveying 1000 caregivers of these high-risk infants to monitor the frequency of death or serious injury associated with using the SNOO Bassinet. It is a postmarket surveillance observational study conducted in accordance with federal safety regulations. Participants include caregivers who have purchased or rented the SNOO Bassinet and whose infants use it from birth up to 6 months old. The study collects data through electronic surveys: an initial eligibility screening one month after purchase or rental, followed by a six-month follow-up survey. The study observes usage patterns, infant age during use, duration of use, and reasons for weaning. Caregivers will complete electronic questionnaires online about their infant's experience with the SNOO Bassinet. The researchers will review reports of any serious injuries or deaths occurring while the infant used the device, investigate these events, and compare findings to population statistics. The study will also analyze usage behaviors and report all findings to the FDA. Participation spans approximately seven months post-purchase or rental.
CONDITIONS
Brief Title
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be the primary caregiver of an infant
- Purchased or rented the SNOO Bassinet shipped to a U.S. residence during the enrollment period
- Caregiver must be an English speaker aged 18 years or older residing in the United States
- Infant must use the SNOO Bassinet between birth and 6 months old
- Infant must meet at least one high-risk criterion for SUID: Black or American Indian/Alaskan Native race; maternal education of 12 years or less; low birth weight under 5 pounds 8 ounces (2500 grams); gestational age less than 37 weeks (preterm); maternal age under 25 years at birth; or maternal smoking during pregnancy
You will not qualify if you...
- Not the primary caregiver
- Does not speak English
- Does not reside in the United States
- Caregiver is younger than 18 years old
- Infant did not use the SNOO Bassinet between birth and 6 months old
- Infant does not meet at least one of the high-risk criteria for SUID: Black or American Indian/Alaskan Native race; maternal education of 12 years or less; low birth weight under 5 pounds 8 ounces (2500 grams); gestational age less than 37 weeks (preterm); maternal age under 25 years at birth; or maternal smoking during pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 electronic screening survey completed approximately 1 month after SNOO purchase or rental ship date
Duration - 6 months
Participants complete a follow-up survey to report outcomes related to SNOO use and any adverse events.
1 electronic follow-up survey completed approximately 7 months after SNOO purchase or rental ship date
Trial Site Locations
Total: 1 location
1
Happiest Baby, Inc.
Los Angeles, California, United States, 90064
Actively Recruiting
Research Team
C
Christopher Laine, PhD
N
Nichole Gogatz
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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