RecruitingNCT06361303

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Sponsor

Happiest Baby, Inc.

Enrollment

1,000 participants

Start Date

Nov 29, 2023

Study Type

OBSERVATIONAL

Conditions

Infant Death Serious Injury

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria12

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

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Interventions

DEVICESNOO 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.