The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

NCT06361303 | Recruiting FDA Device

• 2 other identifiers: PS230001PS230001 / PSS001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Death; Serious Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Infant age during SNOO use

  when infant was 0-6 months old (and still using SNOO)

• Degree of SNOO use

  when infant was 0-6 months old (and still using SNOO)

• Weaning rationale

  when infant was 0-6 months old (and still using SNOO)

Study Arms (1)

SNOO users

Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria

Device: SNOO Bassinet

Interventions

SNOO Bassinet DEVICE

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.

SNOO users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Happiest Baby, Inc.: lead

Study Sites (1)

Happiest Baby, Inc.

Los Angeles, California, 90064, United States

RECRUITING

Related Links

• FDA site for study

MeSH Terms

Conditions

Infant Death

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Laine, PhD

  Happiest Baby, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Laine, PhD

CONTACT

310-476-9358; christopher@happiestbaby.com

Nichole Gogatz

CONTACT

9518379450; ngogatz@happiestbaby.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 11, 2024
• Study Start: November 29, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)