Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants: Clinical, Randomized, Controlled, Crossover
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
研究概览
简要总结
The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the neonatal intensive care unit (NICU).
A NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.
详细描述
The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU. Being the chance prosposta the use of headphones during periods of environmental control has an influence on the level of salivary cortisol and sleep in preterm infants.
This is a randomized clinical trial, controlled, crossover, in which clinical intervention is introduced by the researcher that controls and varies, featuring experimental research.
In this study the intervention being tested is the use of hearing protection in infants. The ear is employed in certain periods of the day. These periods established by the Neonatal Intensive Care Unit (ICU), are intended to promote environmental noise control and manipulation of the NB.
Levels of cortisol present in the saliva of the newborn will be analyzed, allowing to measure the biologically active free cortisol in the body.
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
- None
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature newborn male or female;
- •Inside the incubator;
- •Clinically stable;
- •No change in evoked otoacoustic emissions;
- •Current weight between 1200 to 2000g.
排除标准
- •In phototherapy;
- •In invasive mechanical ventilation and noninvasive;
- •With any type of congenital malformation;
- •Periventricular hemorrhage with grade II, III and IV;
- •In using any medication depressant, analgesic or corticosteroid in last 24 hours;
- •Premature newborn whose mother has a history of illicit drug use during pregnancy.
研究组 & 干预措施
Use of earmuffs
The earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels.
干预措施: use of earmuffs (Device)
No use of earmuffs
No use of earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels.
干预措施: use of earmuffs (Device)
结局指标
主要结局
Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
时间窗: 19 months
The aim of this study was to investigate the influence of the use of earmuffs in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction.
Sleep of premature infants and use of earmuffs
时间窗: 19 months
The aim of this study was to investigate the influence of the use of earmuffs in the sleep in premature infants.
次要结局
未报告次要终点
研究者
Mavilde da Luz Gonçalves Pedreira
Teacher
Federal University of São Paulo