Happiest Baby, Inc.
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 populatio…
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 Ind…
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.
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