NCT01513226已完成不适用
Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants
University Children's Hospital, Zurich0 个研究点目标入组 37 人开始时间: 2006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
- 37
- 主要终点
- mean duration and change over time for total duration per 24 hours for crying variables
研究概览
简要总结
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •very preterm infants (≤ 32 0/7 weeks gestational age, GA)
排除标准
- •major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound
- •retinopathy of prematurity grade III and IV
- •congenital malformations
- •small for gestational age (birth weight < 3rd percentile)
- •prenatal infections
- •intrauterine drug exposure
结局指标
主要结局
mean duration and change over time for total duration per 24 hours for crying variables
时间窗: 5 and 11 weeks corrected age
mean duration per 24 hours for following variables: content, fussing, crying, unsoothable crying change over time, measured at 5 and 11 weeks corrected age measured by diary
次要结局
- mean activity count per 24 hours and change over time(5, 11, and 25 weeks corrected age)
- mean sleep duration per 24 hours and change over time(5,11 and 25 weeks corrected age)
- mean weight gain per day(during hospital stay)
研究者
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