An observational study in Infant Death and Serious Injury, sponsored by Happiest Baby, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Happiest Baby, Inc. · Observational
This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID). This study will survey 1000 caregivers of high-risk infants to examine the frequency of death or serious injury occurring in the SNOO Bassinet.
Synopsis:
This postmarket surveillance study will evaluate the ongoing safety of the Happiest Baby, Inc. SNOO Smart Sleeper in accordance with the order issued under Section 522 of the Federal Food, Drug, and Cosmetic Act, issued March 30, 2023
The study will measure rates of adverse events occurring in the SNOO bassinet from a prospectively screened cohort of 1000 infants determined to be at high risk for SUID. The primary endpoints quantify device-related serious injury and/or device-related death. The secondary endpoints include an analysis of SNOO usage patterns in the enrolled population, including infant age during SNOO use, duration of SNOO use, and weaning rationale.
Procedures:
Prospective participants who have purchased or rented SNOO during the study enrollment period will be invited to participate in an electronic eligibility screening survey 1-month after their purchase/rental ship date. Eligible participants will subsequently be invited to participate in a 6-month follow up survey (7 months after their purchase/rental ship date, 6 months post-enrollment) soliciting self-reported outcomes for the study endpoints. The screening and survey questionnaires will be conducted electronically via Qualtrics using a link provided by email, and which may be completed on a smart phone, tablet, or computer.
As enrolled eligible participants complete their final surveys, responses indicating the occurrence of adverse events will be investigated, classified according to severity and device-relatedness, documented, and reported. A final clinical evaluation of the observed SUID rate will be conducted, and will include reference to demographically-matched population statistics pulled from the CDC WONDER database. A full characterization of adverse events and any demographic or usage-related correlates will be reported to the FDA as part of this investigation.
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.
Infant/caregiver dyads meeting the following inclusion criteria will be eligible for study enrollment:
Infants must meet at least one of the following criteria for high risk for SUID:
Exclusion Criteria:
Infants does NOT meet at least one of the below risk criteria:
Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria
Device: SNOO Bassinet
This is a non-interventional, prospective observational and descriptive active surveillance study of a cohort of individuals who have purchased or rented a SNOO for use with their infant.
Serious Injury
Any instance of SNOO-related serious injury reported (Number and percent), with 'serious' defined as 1) life -threatening, 2) Resulting in permanent impairment of body function or permanent damage to body structure, or 3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Time frame: when infant was 0-6 months old (and still using SNOO)
Infant death
Any instance of device-related infant death (number and percent).
Time frame: when infant was 0-6 months old (and still using SNOO)
Infant age during SNOO use
infant age at start and end of SNOO use
Time frame: when infant was 0-6 months old (and still using SNOO)
Degree of SNOO use
Frequency of SNOO use \[All of the time (\>90%); Most of the time (50-90%); Some of the time (10%-49%); None of the time (\<10%)\]
Time frame: when infant was 0-6 months old (and still using SNOO)
Weaning rationale
Reason for ending SNOO use
Time frame: when infant was 0-6 months old (and still using SNOO)
Plan to share: No
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