Comparison of the Preterm Newborn Sleep With and Without the Use of Earmuffs During the "Quiet Time" in a Neonatal Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Sleep period
研究概览
简要总结
Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects. The aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs use was analyzed through polysomnography measurement during four "Quiet times" periods. It was also analyzed sleep related variables during 24 hours of the day. Preterm newborns characteristics and clinical characteristics were also analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm Newborns inside the incubator;
- •Preterm Newborns clinically stable;
- •Preterm Newborns with no change in hearing screening test;
- •Preterm Newborns current weight between 1200 and 2000g.
排除标准
- •Preterm Newborns in phototherapy;
- •Preterm Newborns in use of invasive mechanical ventilation and noninvasive;
- •Preterm Newborns with any type of congenital malformation;
- •Preterm Newborns with periventricular hemorrhage grades II, III and IV;
- •Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours;
- •Preterm Newborns using corticoids;
- •Preterm Newborn whose mother has a history of illicit drug use during pregnancy
研究组 & 干预措施
earmuffs
Preterm newborns with earmuffs during the Quiet time
干预措施: earmuffs (Device)
control
Preterm newborns without earmuffs during de Quiet time
结局指标
主要结局
Sleep period
时间窗: 4 periods of Quiet time (60 minutes)
categorized as the total time of sleep measured by polysomnography
次要结局
- sleep pattern according to environmental variables(4 periods of Quiet time (60 minutes))
研究者
Mavilde da Luz Gonçalves Pedreira
Escola Paulista de Enfermagem
Federal University of São Paulo