The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHappiest Baby, Inc.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Not primary caregiver
Does not speak English
Is not a US resident
Is not 18 years old or older
Trial population
Caregivers of infants who use SNOO and are at high risk of SUID, as determined by our eligibility criteria. No more than 25% of enrolled subjects will consist of infant users who exclusively used SNOO from birth to 1 month of age. The majority of enrolled subjects (\>50%) will have engaged in SNOO use at some point between 1 and 4 months of infant age. If these enrollment targets are not met, additional subjects will be enrolled until the proposed age distribution and usage criteria are met.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SNOO Bassinet
DeviceThis 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.
Treatment groups
1,900 Participants
are divided into 1 treatment groupGroup A: SNOO users1 intervention
Trial outcomes
Primary outcomes
1
Serious Injury
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.
Time frame
when infant was 0-6 months old (and still using SNOO)2
Infant death
Any instance of device-related infant death (number and percent).
Time frame
when infant was 0-6 months old (and still using SNOO)Secondary outcomes
1
Infant age during SNOO use
infant age at start and end of SNOO use
Time frame
when infant was 0-6 months old (and still using SNOO)2
Degree of SNOO use
Frequency of SNOO use \[All of the time (\>90%); Most of the time (50-90%); Some of the time (10%-49%); None of the time (\<10%)\]
Time frame
when infant was 0-6 months old (and still using SNOO)3
Weaning rationale
Reason for ending SNOO use
Time frame
when infant was 0-6 months old (and still using SNOO)Sponsors and contacts
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Source ClinicalTrials.gov