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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Serious Injury — when infant was 0-6 months old (and still using SNOO) Any instance of SNOO-related serious injury reported (Number and percent), with 'serious' defined as 1) life -threatening, 2) Resulting in permanent impairment of body function or permanent damage to body structure, or 3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Infant death — when infant was 0-6 months old (and still using SNOO) Any instance of device-related infant death (number and percent).
Trial sites (1)
Facility
City
Region
Status
Happiest Baby, Inc.
Los Angeles
California
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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