Recruiting

Observational Study

Sponsor:

Happiest Baby, Inc.

Code:

NCT06361303

Conditions

Infant Death

Serious Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SNOO Bassinet

Study Details

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

Study ID

NCT06361303

Start date

Nov 29, 2023

Status verified date

Aug, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

SNOO users

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

Interventions

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.

Primary outcome measure

  • Serious Injury [ Time Frame: when infant was 0-6 months old (and still using SNOO) ]
  • Infant death [ Time Frame: when infant was 0-6 months old (and still using SNOO) ]

Central Contacts and Locations

Central contacts

Christopher Laine, PhD

310-476-9358christopher@happiestbaby.com

Nichole Gogatz

9518379450ngogatz@happiestbaby.com

Locations

Happiest Baby, Inc.

Recruiting

Los Angeles, California, United States, 90064

Contacts

Christopher Laine, PhD

310-476-4440christopher@happiestbaby.com

Sarah Chang, MPH

310-476-4440schang@happiestbaby.com

Principal Investigator:

Christopher Laine, PhD

More Information

Sponsor

Happiest Baby, Inc.

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Happiest Baby, Inc. on 2025-09-05.