Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Average Heart Rate
研究概览
简要总结
The goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age.
The main questions it aims to answer are:
Primary Objective: To pilot an investigation on the impact of weighted wearable blankets on vital signs and infant movement in healthy infants during nap polysomnogram.
Secondary Objective: To investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep.
详细描述
To date, there is no evaluation of the safety or efficacy of weighted wearable blankets on healthy infants during overnight use in the peer-reviewed scientific literature. These are the conditions in which these products are used by consumers, with infants sleeping unobserved throughout the night. Given the rising popularity in the use of weighted wearable blankets in infants and the risk speculated, a study of the potential impact of weighted wearable blankets on infant vital signs is warranted.
Study Design: Direct observational pilot study of the safety of weighted wearable blankets on a minimum (10) healthy infants aged 0-12 months with nap polysomnogram. Participants will be placed in a weighted wearable blanket, in accordance with their age/weight/height, by their parent or caregiver under the supervision of a member of the study team. After being put to sleep on their back, the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram.
There are stopping parameters (outlined elsewhere) that will be used for this study. If any of the stopping parameters are met, the weighted blanket will be opened to assess if the weighted blanket is responsible for the change. If determined yes, the weighted blanket will be removed and the nap polysomnogram will be terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study
- •0-12 months of age
- •Weight greater than or equal to 8 pounds
- •Gestational age 37 weeks or greater
- •Health status: healthy infant without underlying cardiac, neurological, or pulmonary disorders
- •Infant is naive to a weighted wearable blanket
排除标准
- •Health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder
- •Weight < 8 pounds
- •Gestational age < 37 weeks
- •Gestational use of marijuana, alcohol, or illicit drugs
- •Home environment: use of cigarettes, vaping, e-cigarettes, or marijuana
- •Infant is not naive to a weighted wearable blanket
结局指标
主要结局
Average Heart Rate
时间窗: Day 1, during polysomnogram, up to 8 hours
Measured by EKG
Average Respiratory Rate
时间窗: Day 1, during polysomnogram, up to 8 hours
Measured by Respiratory effort belts
Average Body Temperature
时间窗: Day 1, during polysomnogram, up to 8 hours
Manually measured by ear thermometer
Average Oxygen Saturation
时间窗: Day 1, during polysomnogram, up to 8 hours
Measured by pulse oximetry
Number of Infants With Observed Head Movement
时间窗: Day 1, during polysomnogram, up to 8 hours
The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
Number of Infants With Observed Arm Movement
时间窗: Day 1, during polysomnogram, up to 8 hours
The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
Number of Infants With Observed Body Movement
时间窗: Day 1, during polysomnogram, up to 8 hours
The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
次要结局
- Efficacy of Weighted Wearable Blankets on Sleep Patterns in Healthy Infants During Overnight Sleep(Day 1, during polysomnogram, up to 12 hours)
研究者
Harish Rao
Assistant Professor of Clinical Pediatrics
Indiana University