NCT01550627已完成早期 1 期
Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
University of Jena2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The maximum total serum bilirubin levels
研究概览
简要总结
The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.
详细描述
60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.
Collected data:
- cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy
- The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperbilirubinemia
排除标准
- •Preterm infants > 33 weeks of gestation
结局指标
主要结局
The maximum total serum bilirubin levels
时间窗: within one week after onset of phototherapy
The maximum total serum bilirubin levels within on week after onset of phototherapy
次要结局
未报告次要终点
研究者
Stefanie Junge
(MD)
University of Jena
研究点 (2)
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