Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361303
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-03
Brief Title:
The Happiest Baby Inc SNOO Postmarket Surveillance Study
Sponsor:
Happiest Baby Inc
Organization:
Happiest Baby Inc
Study Overview
Official Title:
The Happiest Baby Inc SNOO Postmarket Surveillance Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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 purchaserental ship date Eligible participants will subsequently be invited to participate in a 6-month follow up survey 7 months after their purchaserental 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
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 andor 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 purchaserental ship date Eligible participants will subsequently be invited to participate in a 6-month follow up survey 7 months after their purchaserental 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
True
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PS230001 PSS001 | OTHER | US FDA | None |