NCT06318637已完成不适用
A Clinical Evaluation of the Acceptability and Feasibility to Caregivers of a Bedtime Routine for Neonates
Johnson & Johnson Consumer Inc. (J&JCI)2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年4月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Bedtime Routine Acceptability and Feasibility to Caregivers
研究概览
简要总结
The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term at birth (gestational age greater than or equal to [>=] 37 weeks)
- •A singleton birth. (Having other infants/children in the household will be allowed but only 1 child per household may be enrolled)
- •Breastfed, formula-fed, or combination
- •Able to read, write, speak, and understand English
- •Must be the parent (biological or adoptive) and legal guardian of the infant participant who is willing and able to present proof of legal guardianship (example: birth certificate/hospital discharge paperwork along with valid ID of legal guardian, etc.)
排除标准
- •Caregiver and infant:
- •Has known allergies or adverse reactions to common topical skincare products or the ingredients in the investigational study materials
- •Has a history of or a concurrent health condition/situation which, in the opinion of the Principal Investigator (PI) or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
- •Is simultaneously participating in any other clinical study or has participated in a clinical study since infant's birth
- •Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
- •Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, or erythema)
结局指标
主要结局
Bedtime Routine Acceptability and Feasibility to Caregivers
时间窗: At 6 months
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
次要结局
未报告次要终点
研究者
研究点 (2)
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