CTRI/2018/02/011740尚未招募不适用
A comparison of two targets of serum bilirubin concentration for phototherapy discontinuation in neonatal jaundice.
Veda Senthil Velan Ganesan1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Number of babies who require re-initiation of phototherapy.
研究概览
简要总结
This study is a randomized, open labelled, parallel group, single centre study comparing the occurance of significant rebound jaundice when phototherapy was stopped in two targets below the treatment threshold in babies with neonatal jaundice. Secondary outcomes will be compared are total duration of phototherapy and total duration of hospital stay in two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Babies with gestational age ≥35 weeks, 2)Babies with birth weight >1800 grams, 3)Babies requiring phototherapy for the first time, 4)Babies with onset of jaundice ≤7 days.
排除标准
- •Babies planned for immediate exchange transfusion at the time of admission.
结局指标
主要结局
Number of babies who require re-initiation of phototherapy.
时间窗: 24 hours after stopping phototherapy
次要结局
- Total duration of phototherapy including treatment after rebound hyperbilirubinemia and total duration of hospital stay.(Less than 7 days)
研究者
研究点 (1)
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