The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

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.

Conditions

Infant Death, Serious Injury

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Study Overview

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Study Details

Study overview

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.

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

The Happiest Baby, Inc. SNOO Postmarket Surveillance Study

Condition
Infant Death
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Happiest Baby, Inc., Los Angeles, California, United States, 90064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Happiest Baby, Inc.,

Christopher Laine, PhD, PRINCIPAL_INVESTIGATOR, Happiest Baby, Inc.

Study Record Dates

2025-09