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The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Happiest Baby, Inc. · NCT06361303

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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
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study (NCT06361303) | Bored Studies