Safety Monitoring of the Happiest Baby SNOO Smart Sleeper Bassinet For Infants at High Risk of Sudden Unexpected Infant Death

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 infants 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.

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study