Evaluating the safety of the SNOO Smart Sleeper for high-risk infants

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

This study is trying to see if the SNOO Smart Sleeper is safe for high-risk infants by checking in with caregivers about any serious injuries or deaths over six months.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Happiest Baby, Inc. (Industry-sponsored)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06361303 on ClinicalTrials.gov

What this trial studies

This observational study assesses the safety of the SNOO Smart Sleeper Bassinet for infants at high risk for Sudden Unexpected Infant Death (SUID). It involves surveying 1000 caregivers of these infants to track the occurrence of serious injuries or deaths associated with the use of the SNOO. Participants will complete an electronic eligibility screening and follow-up surveys to report any adverse events over a six-month period. The study aims to gather data on usage patterns and outcomes related to the device.

Who should consider this trial

Good fit: Ideal candidates include primary caregivers of infants who are at high risk for SUID and have purchased or rented a SNOO Bassinet.

Not a fit: Patients who do not meet the high-risk criteria for SUID or are not primary caregivers will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical safety data that may enhance the use of the SNOO Bassinet for protecting high-risk infants.

How similar studies have performed: While this study focuses on postmarket surveillance, similar studies evaluating infant sleep safety devices have shown promising results in improving safety outcomes.

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

Where this trial is running

Los Angeles, California

• Happiest Baby, Inc. — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Christopher Laine, PhD — Happiest Baby, Inc.
• Study coordinator: Christopher Laine, PhD

Conditions Infant Death; Serious Injury