Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- heart rate
研究概览
简要总结
The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression Scale .
详细描述
The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group. A IntelliVue physiological monitor and a behavior scale collects ECG, respiratory rate, SpO2 concentration, and sleep/awake states of premature infants in both groups. Finally, ANOVA analyzes the statistical significance between the measurer and items.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants at 28-36 gestational age
- •Within 10 days in NICU after delivery
排除标准
- •Has a known chromosomal or congenital abnormality
- •Major congenital infection
- •Brain lesions diagnosed prenatally, or neonatal asphyxia at birth.
- •Toxic use by the mother during pregnancy
- •Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination
- •Are using sedative medication
- •Premature infants use endotracheal tube respirator or high-frequency respirator
- •Preterm infants requiring immediate surgical treatment at birth
结局指标
主要结局
heart rate
时间窗: 14th day
observation at 7th and 14th day after intervention period
respiratory rate
时间窗: 14th day
observation at 7th and 14th day after intervention period
SpO2 concentration
时间窗: 14th day
observation at 7th and 14th day after intervention period
behavioral status with crying states of premature infants
时间窗: 14th day
observation at 7th and 14th day after intervention period
次要结局
未报告次要终点
研究者
Chia-Jung Lin
nurse practitioner
Far Eastern Memorial Hospital