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The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

NCT06361303 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Happiest Baby, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Laine, PhD · Happiest Baby, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06361303 on ClinicalTrials.gov