NCT06361303 · Happiest Baby, Inc.
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations