NCT03120702已完成不适用
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
研究概览
简要总结
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care.
- •Ages: Newborn infants less than 16 weeks postnatal age.
- •Weight: Range from 500 g to 10 kg.
- •Able to obtain written informed consent from parents or legal guardians
排除标准
- •Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.
结局指标
主要结局
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
时间窗: duration of surgery
To study the SpHb sensor in neonatal population.
次要结局
未报告次要终点
研究者
研究点 (2)
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