Infant DeathNCT06361303
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
An observational study of Infant Death and Serious Injury, run by Happiest Baby, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infant Death, Serious Injury
- What is being tested?
- SNOO Bassinet
- Type of treatment
- Medical device
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2023to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Happiest Baby, Inc.
Los Angeles, California, 90064
Christopher Laine, PhD, 310-476-4440, christopher@happiestbaby.com
Nichole Gogatz, 951-837-9450, ngogatz@happiestbaby.com
About this study
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.
Read the detailed description
Synopsis:
This postmarket surveillance study will evaluate the ongoing safety of the Happiest Baby, Inc. SNOO Smart Sleeper in accordance with the order issued under Section 522 of the Federal Food, Drug, and Cosmetic Act, issued March 30, 2023
The study will measure rates of adverse events occurring in the SNOO bassinet from a prospectively screened cohort of 1000 infants determined to be at high risk for SUID. The primary endpoints quantify device-related serious injury and/or device-related death. The secondary endpoints include an analysis of SNOO usage patterns in the enrolled population, including infant age during SNOO use, duration of SNOO use, and weaning rationale.
Procedures:
Prospective participants who have purchased or rented SNOO during the study enrollment period will be invited to participate in an electronic eligibility screening survey 1-month after their purchase/rental ship date. Eligible participants will subsequently be invited to participate in a 6-month follow up survey (7 months after their purchase/rental ship date, 6 months post-enrollment) soliciting self-reported outcomes for the study endpoints. The screening and survey questionnaires will be conducted electronically via Qualtrics using a link provided by email, and which may be completed on a smart phone, tablet, or computer.
As enrolled eligible participants complete their final surveys, responses indicating the occurrence of adverse events will be investigated, classified according to severity and device-relatedness, documented, and reported. A final clinical evaluation of the observed SUID rate will be conducted, and will include reference to demographically-matched population statistics pulled from the CDC WONDER database. A full characterization of adverse events and any demographic or usage-related correlates will be reported to the FDA as part of this investigation.
- Conditions
- Infant Death, Serious Injury
- Being tested
- SNOO Bassinet
- Medical subject headings
- Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNOO BassinetDevice
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 group | Role | What they receive |
|---|---|---|
| SNOO users | Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria Receives: Device: SNOO Bassinet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: when infant was 0-6 months old (and still using SNOO)
Infant death
Any instance of device-related infant death (number and percent).
Measured: when infant was 0-6 months old (and still using SNOO)
Secondary outcomes (3)
Infant age during SNOO use
infant age at start and end of SNOO use
Measured: when infant was 0-6 months old (and still using SNOO)
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%)]
Measured: when infant was 0-6 months old (and still using SNOO)
Weaning rationale
Reason for ending SNOO use
Measured: when infant was 0-6 months old (and still using SNOO)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start29 Nov 2023
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Happiest Baby, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Christopher Laine, Happiest Baby, Inc.
- Investigators
- Christopher Laine, PhD, Principal investigator, Happiest Baby, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361303
- Sponsor's protocol ID
- PS230001
- Other IDs
- PS230001 / PSS001
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
- ClinicalTrials.gov ID
- NCT06361303
- Acronym / sponsor ID
- PS230001
- Conditions
- Infant Death, Serious Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Happiest Baby, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Synopsis:
This postmarket surveillance study will evaluate the ongoing safety of the Happiest Baby, Inc. SNOO Smart Sleeper in accordance with the order issued under Section 522 of the Federal Food, Drug, and Cosmetic Act, issued March 30, 2023
The study will measure rates of adverse events occurring in the SNOO bassinet from a prospectively screened cohort of 1000 infants determined to be at high risk for SUID. The primary endpoints quantify device-related serious injury and/or device-related death. The secondary endpoints include an analysis of SNOO usage patterns in the enrolled population, including infant age during SNOO use, duration of SNOO use, and weaning rationale.
Procedures:
Prospective participants who have purchased or rented SNOO during the study enrollment period will be invited to participate in an electronic eligibility screening survey 1-month after their purchase/rental ship date. Eligible participants will subsequently be invited to participate in a 6-month follow up survey (7 months after their purchase/rental ship date, 6 months post-enrollment) soliciting self-reported outcomes for the study endpoints. The screening and survey questionnaires will be conducted electronically via Qualtrics using a link provided by email, and which may be completed on a smart phone, tablet, or computer.
As enrolled eligible participants complete their final surveys, responses indicating the occurrence of adverse events will be investigated, classified according to severity and device-relatedness, documented, and reported. A final clinical evaluation of the observed SUID rate will be conducted, and will include reference to demographically-matched population statistics pulled from the CDC WONDER database. A full characterization of adverse events and any demographic or usage-related correlates will be reported to the FDA as part of this investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNOO users | – | Device: SNOO BassinetCaregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNOO BassinetThis 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. | Device | SNOO users |
Primary outcome
Serious Injury
Time frame: 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
Time frame: when infant was 0-6 months old (and still using SNOO)
Any instance of device-related infant death (number and percent).
3 secondary outcomes
Infant age during SNOO use
Time frame: when infant was 0-6 months old (and still using SNOO)
Degree of SNOO use
Time frame: when infant was 0-6 months old (and still using SNOO)
Weaning rationale
Time frame: when infant was 0-6 months old (and still using SNOO)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- FDA site for studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Infant Death
Recruiting
Infant Safe Sleep in Pediatric Emergency Depratment
Infant Safe Sleep Practices, SIDS
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Active, not recruitingPhase 2/3
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type II, Metabolic Diseases
Active, not recruitingPhase 2/3
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
Mucopolysaccharidosis II
Active, not recruitingObservational study
Long-term Follow-Up for RGX-121
Mucopolysaccharidosis II
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Laine, PhD principal investigator
Happiest Baby, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Death and Serious Injury, run by Happiest Baby, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Laine, PhD (310-476-9358, christopher@happiestbaby.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Injury (time frame: when infant was 0-6 months old (and still using SNOO)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.