[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543856":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":54,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Happiest Baby, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SNOO users",null,"Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria",[13],"Device: SNOO Bassinet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21],{"name":22,"affiliation":5,"role":23},"Christopher Laine, PhD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","310-476-9358","christopher@happiestbaby.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Nichole Gogatz","9518379450","ngogatz@happiestbaby.com",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Los Angeles","California","90064","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-118.24368,34.05223,{"lat":45,"lon":44},[48,50,53],{"name":22,"role":26,"phone":49,"phoneExt":10,"email":28},"310-476-4440",{"name":51,"role":26,"phone":49,"phoneExt":10,"email":52},"Sarah Chang, MPH","schang@happiestbaby.com",{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":23,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Christopher Laine","Principal Research Scientist","100543856","the-happiest-baby-inc-snoo-postmarket-surveillance-study-100543856",false,"NCT06361303","The Happiest Baby, Inc. SNOO Postmarket Surveillance Study","Inclusion Criteria:\n\nInfant\u002Fcaregiver dyads meeting the following inclusion criteria will be eligible for study enrollment:\n\n* Respondent must identify as a primary caregiver of the infant.\n* Purchase or rental of SNOO shipped to a U.S. residence during the defined enrollment period.\n* Caregivers must be English speakers ages 18 or older residing in the United States.\n* Infants must use SNOO during the intended use period (i.e., birth to 6 months).\n* Infants must meet at least one of the following criteria for high risk for SUID:\n\n  * Infant race: Black or African American; and\u002For American Indian or Alaskan Native\n  * Maternal education: 12 years or less\n  * Low birth weight: \\\u003C5 pounds 8 ounces (\\\u003C2500 grams)\n  * Last menstrual cycle (LMP) or obstetrical estimate (OE) Gestational age at time of birth: \\\u003C37 weeks (preterm)\n  * Maternal age at time of birth: \\\u003C25 years\n  * Smoking status: Any self-reported maternal smoking during pregnancy\n\nExclusion Criteria:\n\n* Not primary caregiver\n* Does not speak English\n* Is not a US resident\n* Is not 18 years old or older\n* Infant did not use SNOO during the intended use period (i.e., birth to 6 months).\n* Infants does NOT meet at least one of the below risk criteria:\n\n  * Infant race: Black or African American; and\u002For American Indian or Alaskan Native\n  * Maternal education: 12 years or less\n  * Low birth weight: \\\u003C5 pounds 8 ounces (\\\u003C2500 grams)\n  * LMP or OE Gestational age at time of birth: \\\u003C37 weeks (preterm)\n  * Maternal age at time of birth: \\\u003C25 years\n  * Smoking status: Any self-reported maternal smoking during pregnancy",true,"ALL","18 Years",{"count":67,"type":68},1000,"ESTIMATED","OBSERVATIONAL","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.",[72,73],"Infant Death","Serious Injury","2025-09-04",{"date":76,"type":77},"2025-09-05","ACTUAL",{"date":79,"type":77},"2023-11-29",{"date":81,"type":68},"2026-05",{"name":5,"class":6},1]