|
General |
Study Status |
Ongoing |
522 Number / Requirement Number |
PS230001 / PSS001 |
Date Original Plan Accepted |
07/27/2023
|
Study Name |
SNOO Smart Sleeper
|
Device Name |
Snoo smart sleeper
|
Root Document Number |
DEN210039
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Historical Control
|
Analysis Type |
Descriptive
|
Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
Non-interventional, prospective observational and descriptive active surveillance study. Postmarket surveillance study of infants who use SNOO and are at high risk of SIDS/SUID to determine the rates of serious injury and death, including from inadequate securement or inadequate positioning of the infant.
|
Study Population |
Infants 0-6 months who used the SNOO during the first 6 months
|
Sample Size |
Number of subjects: 1,000 Sites location: Users/caregivers homes that rent or purchase the SNOO.
|
Key Study Endpoints |
Safety Endpoints Primary: Incidence of respondent-reported device-related serious injury and/or device-related death. Secondary: Infant age during SNOO use. Degree of SNOO use. Weaning rationale. Effectiveness Endpoints Primary: Any instance of device-related serious injury (#/%), which is defined as injury or illness that: (1) Is life-threatening; (2) Results in permanent impairment of a body function or permanent damage to a body structure, or (3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Any instance of device-related infant death (#/%) Secondary: Infant age at the start of SNOO use - Infant age at the end of SNOO use. Frequency of SNOO use [All of the time (>90%); Most of the time (50-90%); Some of the time (10%-50%); None of the time (<10%) Reason for ending SNOO use.
|
Follow-up Visits and Length of Follow-up |
Prospective enrollment at 1 month following SNOO ship date with 6- month follow up questionnaire (7 months post-ship date) for data collection of study endpoints
|