The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
Recruiting
Observational Study
Infant DeathSerious Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,900 (estimated)
Sponsor
Happiest Baby, Inc. · Industry
Who this trial is looking for
This trial is looking for primary caregivers of high-risk infants. Participants will answer questions about the SNOO Bassinet's safety regarding serious injury or death.
Are You a Good Fit for This Trial?
You may be able to join if
I am the primary caregiver for my infant.
I live in the United States.
I am 18 years old or older.
I speak English.
My infant was born between 0 to 6 months ago.
My infant is at high risk for Sudden Unexpected Infant Death.
You may not be able to join if
I am not the primary caregiver.
I do not speak English.
I do not live in the United States.
I am younger than 18 years old.
My infant is older than 6 months.
My infant is not at high risk for Sudden Unexpected Infant Death.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 mu…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.