The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent of Quiet Sleep Time During 3-hour Sleep Assessment
研究概览
简要总结
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are:
- Do preterm infants who sleep in the SNOO have more quiet sleep?
- Do preterm infants who sleep in the SNOO have improved vital signs?
- Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments.
- Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels).
- Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG).
There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.
详细描述
Sleep plays an important role in the brain growth and development of preterm infants. Neonatal sleep is made up of three stages of sleep: quiet sleep, active sleep, and transitional sleep. Poor sleep can be a result of premature birth itself as well as from simply being in the neonatal intensive care unit (NICU) environment. The interruptions that these infants are exposed to include frequent cares, physical exams, lights, and noises.
The investigators are interested in the potential positive effects on sleep of recreating the environment of the womb. The SNOO is a bassinet that uses the combination of a secure swaddle, white noise, and gentle rocking movements to mimic the conditions that infants were exposed to in the uterus before being born. The investigators are interested in studying how recreating this environment of "within the womb" impacts the sleep-wake cycles of premature infants. To do this, the investigators will measure the amount of time that premature infants spent asleep versus awake while in the SNOO through behavior observations, electroencephalogram (brain activity monitoring), and vital signs. The investigators hypothesize that sleeping in the SNOO will increase the amount of time that the premature infants spend in quiet sleep and will improve their vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inpatients at the Morgan Stanley Children's Hospital NICU.
- •Singleton gestation.
- •Gestational age 28w0d to 36w6d at birth.
- •Postmenstrual age greater than 35 weeks at the time of the intervention.
- •Weight greater than 1.8 kg and less than 11.3 kg.
- •Stable thermoregulation in an open crib.
- •Stable respiratory status on room air (no nasal cannula or CPAP).
- •Normal head ultrasound (if obtained).
排除标准
- •Congenital brain or spinal anomalies.
- •Intracranial hemorrhage.
- •Severe encephalopathy.
- •Known or suspected genetic syndromes that could result in cerebral dysfunction.
- •Airway anomalies that could result in sleep-disordered breathing.
- •Bleeding diatheses.
- •Status post surgery or minor surgical procedures (i.e. inguinal hernia repair, circumcision).
- •Fetal opioid exposure.
- •Administration of sedating agents over the past 24 hours.
- •Ability to independently roll to hands and knees.
研究组 & 干预措施
Traditional bassinet group
The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
干预措施: Traditional bassinet (Device)
SNOO group
The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.
干预措施: SNOO Smart Sleeper (Device)
结局指标
主要结局
Percent of Quiet Sleep Time During 3-hour Sleep Assessment
时间窗: At baseline sleep assessment, up to 3 hours
Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid "rag doll" appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds.
次要结局
- Change in Heart Rate Variability(At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours))
- Change in Cerebral Oxygenation(At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours))
- Change in Oxygen Saturation(At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours))
- Change in Intermittent Hypoxemic Event Frequency(At baseline sleep assessment (up to 3 hours) and second sleep assessment (up to 3 hours))
- Change in Oxygen Saturation(Up to 3 hours)
- Change in Intermittent Hypoxemic Event Frequency(Up to 3 hours)
- Change in Heart Rate Variability(Up to 3 hours)
- Change in Cerebral Oxygenation(Up to 3 hours)
研究者
Rakesh Sahni
Medical Director of the Neonatal Intensive Care Unit at NewYork-Presbyterian/Morgan Stanley Children's Hospital
Columbia University