The Happiest Baby, Inc. SNOO Postmarket Surveillance Study (NCT06361303) | Clinical Trial Compass
RecruitingNot Applicable
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
United States1,000 participantsStarted 2023-11-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Serious Injury
Timeframe: when infant was 0-6 months old (and still using SNOO)
2
Infant death
Timeframe: when infant was 0-6 months old (and still using SNOO)