Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT06361303
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06361303
Study Brief:
Protocol Section:
NCT06361303