The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

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.

Study Overview

• Status: Recruiting
• Conditions: Infant Death; Serious Injury
• Intervention / Treatment: Device: 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 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Christopher Laine, PhD; Phone Number: 310-476-9358; Email: christopher@happiestbaby.com
• Study Contact Backup: Name: Nichole Gogatz; Phone Number: 9518379450; Email: ngogatz@happiestbaby.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90064
      • Recruiting
      • Happiest Baby, Inc.
      • Contact: Christopher Laine, PhD; Phone Number: 310-476-4440; Email: christopher@happiestbaby.com
      • Contact: Sarah Chang, MPH; Phone Number: 310-476-4440; Email: schang@happiestbaby.com
      • Principal Investigator: Christopher Laine, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Caregivers of infants who use SNOO and are at high risk of SUID, as determined by our eligibility criteria. No more than 25% of enrolled subjects will consist of infant users who exclusively used SNOO from birth to 1 month of age. The majority of enrolled subjects (>50%) will have engaged in SNOO use at some point between 1 and 4 months of infant age. If these enrollment targets are not met, additional subjects will be enrolled until the proposed age distribution and usage criteria are met.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SNOO users; Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Infant death	Any instance of device-related infant death (number and percent).	when infant was 0-6 months old (and still using SNOO)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Weaning rationale	Reason for ending SNOO use	when infant was 0-6 months old (and still using SNOO)

Collaborators and Investigators

• Sponsor: Happiest Baby, Inc.
• Investigators: Principal Investigator: Christopher Laine, PhD, Happiest Baby, Inc.

Publications and helpful links

Helpful Links

• FDA site for study

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Pathological Conditions, Signs and Symptoms; Infant Death
• Other Study ID Numbers: PS230001; PS230001 / PSS001 (Other Identifier: US FDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No