NCT00648687已完成不适用
Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
National Bioethics Commission of Brazil1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年3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
- 100
- 试验地点
- 1
- 主要终点
- Pain secondary to eye examination
研究概览
简要总结
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). NIPS scale will be applied two minutes before examination and two minutes after examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age
排除标准
- •the ones that died before 6 weeks old
结局指标
主要结局
Pain secondary to eye examination
时间窗: 2 minutes after the exam
次要结局
未报告次要终点
研究者
研究点 (1)
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