NCT00565357已完成不适用
Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)0 个研究点目标入组 34 人开始时间: 2002年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.
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
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birthweight between 401 and 1500 grams
- •less than 1 week of age
- •parental informed consent
- •availability of research personnel
排除标准
- •terminal illness
- •congenital anomalies
- •syndromes associated with hearing loss
结局指标
主要结局
Weight
时间窗: 34 weeks post-menstrual age
次要结局
- Length of stay in neonatal intensive care(hospital discharge)
- Time on mechanical ventilator(hospital discharge)
- Weight(18 - 22 months of age)
- Length(18 - 22 months of age)
- Frontal-occipital circumference(18 - 22 months of age)
- Bayley Mental Developmental Index(18 - 22 months of age)
- Bayley Psychomotor Developmental Index(18 - 22 months of age)
- ABR Hearing Screen(hospital discharge)
研究者
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