Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06361303

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Led by Happiest Baby, Inc. · Updated on 2025-09-05

1000

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (birth to 6 months).
  • Infants must meet at least one high-risk criteria for SUID: Black or African American; and/or American Indian or Alaskan Native; maternal education 12 years or less; low birth weight less than 5 pounds 8 ounces (less than 2500 grams); gestational age at birth less than 37 weeks (preterm); maternal age at birth less than 25 years; any self-reported maternal smoking during pregnancy.
Not Eligible

You will not qualify if you...

  • 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 (birth to 6 months).
  • Infant does not meet at least one high-risk criteria for SUID: Black or African American; and/or American Indian or Alaskan Native; maternal education 12 years or less; low birth weight less than 5 pounds 8 ounces (less than 2500 grams); gestational age at birth less than 37 weeks (preterm); maternal age at birth less than 25 years; any self-reported maternal smoking during pregnancy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Happiest Baby, Inc.

Los Angeles, California, United States, 90064

Actively Recruiting

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Research Team

C

Christopher Laine, PhD

CONTACT

N

Nichole Gogatz

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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