The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,900
- 试验地点
- 2
- 主要终点
- Serious Injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SNOO users
Caregivers who use the SNOO Bassinet with their infant and who meet eligibility criteria
干预措施: SNOO Bassinet (Device)
结局指标
主要结局
Serious Injury
时间窗: when infant was 0-6 months old (and still using SNOO)
Any instance of SNOO-related serious injury reported (Number and percent), with 'serious' defined as 1) life -threatening, 2) Resulting in permanent impairment of body function or permanent damage to body structure, or 3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Infant death
时间窗: when infant was 0-6 months old (and still using SNOO)
Any instance of device-related infant death (number and percent).
次要结局
- Infant age during SNOO use(when infant was 0-6 months old (and still using SNOO))
- Degree of SNOO use(when infant was 0-6 months old (and still using SNOO))
- Weaning rationale(when infant was 0-6 months old (and still using SNOO))
研究者
Christopher Laine
Principal Research Scientist
Happiest Baby, Inc.