The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Infant Death Clinical Trial

Official title:

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06361303
• Other study ID #: PS230001
• Secondary ID: PS230001 / PSS00
• Status: Recruiting
• Start date: November 29, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Happiest Baby, Inc.
• Contact: Christopher Laine, PhD
• Phone: 310-476-9358
• Email: christopher[@]happiestbaby.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 and/or 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 purchase/rental ship date. Eligible participants will subsequently be invited to participate in a 6-month follow up survey (7 months after their purchase/rental 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Indian or Alaskan Native
• Maternal education: 12 years or less
• Low birth weight: <5 pounds 8 ounces (<2500 grams)
• Last menstrual cycle (LMP) or obstetrical estimate (OE) Gestational age at time of birth: <37 weeks (preterm)
• Maternal age at time of birth: <25 years
• Smoking status: Any self-reported maternal smoking during pregnancy

Exclusion Criteria:

• Not primary caregiver
• Does not speak English
• Is not a US resident
• Is not 18 years old or older
• Infant did not use SNOO during the intended use period (i.e., birth to 6 months).
• Infants does NOT meet at least one of the below risk criteria:
• Infant race: Black or African American; and/or American Indian or Alaskan Native
• Maternal education: 12 years or less
• Low birth weight: <5 pounds 8 ounces (<2500 grams)
• LMP or OE Gestational age at time of birth: <37 weeks (preterm)
• Maternal age at time of birth: <25 years
• Smoking status: Any self-reported maternal smoking during pregnancy

Related Conditions & MeSH terms

• Infant Death

Intervention

Device:
• SNOO Bassinet
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.

Locations

Country	Name	City	State
United States	Happiest Baby, Inc.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Happiest Baby, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Injury	Any instance of SNOO-related serious injury reported (Number and percent), with 'serious' defined as 1) life -threatening, 2) Resulting in permanent impairment of body function or permanent damage to body structure, or 3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.	when infant was 0-6 months old (and still using SNOO)
Primary	Infant death	Any instance of device-related infant death (number and percent).	when infant was 0-6 months old (and still using SNOO)
Secondary	Infant age during SNOO use	infant age at start and end of SNOO use	when infant was 0-6 months old (and still using SNOO)
Secondary	Degree of SNOO use	Frequency of SNOO use [All of the time (>90%); Most of the time (50-90%); Some of the time (10%-49%); None of the time (<10%)]	when infant was 0-6 months old (and still using SNOO)
Secondary	Weaning rationale	Reason for ending SNOO use	when infant was 0-6 months old (and still using SNOO)

External Links

•   FDA site for study