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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Christopher Laine, PhD — Happiest Baby, Inc.
• Study coordinator: Christopher Laine, PhD
• Email: christopher@happiestbaby.com
• Phone: 310-476-9358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.