The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Happiest Baby, Inc. · NCT06361303
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 1900
- US sites recruiting
- 1
- Study start
- November 29, 2023
- Record last updated
- September 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: SNOO Bassinet
Conditions: Infant Death; Serious Injury
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Happiest Baby, Inc.
Los Angeles, CA 90064
Site contact: Christopher Laine, PhD · 310-476-4440 · christopher@happiestbaby.com
Study contacts (from the official record)
- Christopher Laine, PhD · 310-476-9358 · christopher@happiestbaby.com
- Nichole Gogatz · 9518379450 · ngogatz@happiestbaby.com
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