The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Happiest Baby, Inc.
Study ID
NCT06361303
Status
Recruiting
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Conditions

  • Infant Death
  • Serious Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Nov 29, 2023
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: SNOO users
    Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Happiest Baby, Inc.Los AngelesCalifornia90064
Christopher Laine, PhD
[email protected]
310-476-4440
Sarah Chang, MPH
[email protected]
310-476-4440
Christopher Laine, PhD (PRINCIPAL_INVESTIGATOR)

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Happiest Baby, Inc.· Los Angeles, CA

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