A Pilot Study Evaluating Sleep, Stress, and Infant Nutrition Using a Chatbot With Parents of Preterm and Full-term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Chats on Sleep, Stress and Infant Nutrition
研究概览
简要总结
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.
详细描述
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot.
Data obtained from parents of preterm infants and parents of full-term infants on sleep, stress, and infant nutrition will be compared.
An evaluation of the usability of the mobile app hosting the chatbot, the study chatbot and its functionality in general among this population will also be conducted
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects (parent and infant) must meet the following criteria:
- •Healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment
- •Infants must be at home (discharged from the hospital) at time of enrollment
- •Informed consent from parent whose age is ≥21 years
- •Parent must be proficient in the English language
- •Parent must be able to comply with the required study tasks, as per PI's judgment
- •In-home access to reliable internet connections; a mobile device suitable for electronic communication
排除标准
- •Infant must not meet any of the following criteria:
- •Known to have current or previous illnesses/conditions which could interfere with the study outcome (per PI's clinical judgment)
- •Must not be currently participating in any other clinical study
- •Parent must not meet any of the following criteria:
- •Must not be known to have a significant medical condition that might interfere with the study (per PI's clinical judgment) that meets one of the following criteria:
- •Presence of current mental illness or history of mental illness
- •Any acute or chronic illness that makes the parent unsuitable for the study based on the PI's judgment
- •Must not be a single parent
- •Inability of the parent to comply with the study protocol or PI's uncertainty about the willingness or ability of the parent to comply with the protocol requirements
结局指标
主要结局
Number of Chats on Sleep, Stress and Infant Nutrition
时间窗: 8 weeks
Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot
次要结局
- Particular Reasons for Stress Caused by the Baby(8 weeks)
- Ratings by Parents of Quality of Their Sleep(8 weeks)
- Number of Chats on Feedings Among Parents Who Give Their Infants Formula(8 weeks)