The Effect of Maternal Scent on Sleep Wake States, Brain Maturation, and Heart Rate Variability: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Percentage of time spent in quiet sleep
研究概览
简要总结
This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to either 24 hours of exposure to maternal scent or standard of care. Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured using several electroencephalogram (EEG) parameters. Heart rate variability will be collected as part of vital sign collection.
详细描述
Sleep is important for the growth and development of infants. There are different states that make up sleep wake cycles including quiet sleep, active sleep, and transitional sleep. The amount of time that infants spend in quiet sleep increases as they mature. There are different tools that can be used to measure sleep state including EEG, behavior, and vital signs. Recent research has looked at ways to improve sleep in infants admitted to the NICU including music and maternal voice. The investigators are interested in studying maternal scent. Maternal scent has been shown to improve infant feeding and to reduce infant crying during painful procedures. Therefore, the investigators are interested in studying how maternal scent might affect sleep wake state in infants admitted to the NICU. The investigators will observe infant behavior and use EEG and vital signs to assess sleep state in infant after they are exposed to maternal scent.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at 30 weeks gestation to 36 weeks gestation.
排除标准
- •Infants with congenital anomalies, neonatal abstinence syndrome, or head ultrasound findings of grade II intraventricular hemorrhage or greater.
- •Infants participating in studies with similar interventions.
研究组 & 干预措施
Maternal Scent Group
Infants in this group will be exposed to a breast pad worn by their mothers to extract maternal scent. This exposure will last 24 hours.
干预措施: Maternal Scent (Other)
Control Group
Infants in this group will receive standard of care.
结局指标
主要结局
Percentage of time spent in quiet sleep
时间窗: 2 hours
Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in quiet sleep.
Percentage of time spent active sleep
时间窗: 2 hours
Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in active sleep.
次要结局
- Beta to theta ratio(2 hours)
- Number of mothers diagnosed with acute stress disorder based on score on the Stanford Acute Stress Reaction Questionnaire (SASRQ)(2 hours)