NCT06361303 The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
| NCT ID | NCT06361303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Happiest Baby, Inc. |
| Condition | Infant Death |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2023-11-29 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,900 participants in total. It began in 2023-11-29 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Christopher Laine, PhD
PRINCIPAL INVESTIGATOR
Happiest Baby, Inc.
Frequently Asked Questions
Who can join the NCT06361303 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infant Death. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06361303 currently recruiting?
Yes, NCT06361303 is actively recruiting participants. Contact the research team at christopher@happiestbaby.com for enrollment information.
Where is the NCT06361303 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06361303 clinical trial?
NCT06361303 is sponsored by Happiest Baby, Inc.. The principal investigator is Christopher Laine, PhD at Happiest Baby, Inc.. The trial plans to enroll 1,900 participants.