A Randomized Controlled Trial of Kangaroo Care (Skin-to-Skin) Effects on Sleep in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- EEG-based sleep
研究概览
简要总结
90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3 hours, then fed, then KC group was placed in KC and control group remained in incubator for a 2-3 hr test period. EEG measures of sleep, HR, and RR were taken. .
详细描述
The neonatal intensive care unit (NICU) environment is not conducive to sleep, and infant sleep in incubators is fragmented. Sleep contributes to brain maturation so interventions to foster sleep are needed. During Kangaroo Care (KC) behavioral indicators of Quiet Sleep have been observed but, not confirmed by objective electroencephalographic (EEG) analysis.The purpose was to determine the effects of Kangaroo Care (KC) on EEG-based sleep using Nihon Koden polysomnography and cardiorespiratory patterns by comparing KC sleep to incubator sleep.. A randomized controlled study with 90 preterms (KC = 50; control = 40) in which KC infants received 2-3 hours of KC between feeds after a comparable pretest period in an incubator and control infants remained in an incubator during the 2-3 hour pretest and test periods. In the incubator infants were inclined, prone, and nested; in KC infants were inclined, prone, and chest-to-chest underneath a blanket. The medically stable preterm infants were a mean 32 weeks postmenstrual age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects whose five-minute APGARS were greater than 6, gestational age was 28 or more weeks at birth, and whose testing weight was greater than 1000 grams were included.
排除标准
- •Infants with encephalopathy, intraventricular hemorrhage greater than grade II, white matter lucencies on cranial ultrasound, seizures, meningitis, or congenital brain malformations were excluded
结局指标
主要结局
EEG-based sleep
时间窗: 2-3 hours
Infants attached to EEG machine and Respiratory impedance plethysmography bands prior to beginning of pretest period and remainded on EEG until end of study
次要结局
- Heart rates during pretest(2-3 hours of pretest)
- Respiratory rate during pretest(2-3 hours pretest)
- Respiratory rate during test period(2-3 hours test period)
- Heart rates during test(2-3 hours of test)
研究者
Susan Ludington
Walters Professor of Pediatric Nursing
Case Western Reserve University