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|
| 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
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