Clinical trial NCT06361303: The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Official title: The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Death
Serious Injury
Lead sponsor: Happiest Baby, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

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

Primary outcomes:
measure: Serious Injury
timeFrame: when infant was 0-6 months old (and still using SNOO)
measure: Infant death
timeFrame: when infant was 0-6 months old (and still using SNOO)
Secondary outcomes:
measure: Infant age during SNOO use
timeFrame: when infant was 0-6 months old (and still using SNOO)
measure: Degree of SNOO use
timeFrame: when infant was 0-6 months old (and still using SNOO)
measure: Weaning rationale
timeFrame: when infant was 0-6 months old (and still using SNOO)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Happiest Baby, Inc.
state: California
Study officials:
affiliation: Happiest Baby, Inc.
name: Christopher Laine, PhD
role: PRINCIPAL_INVESTIGATOR
References: