NCT02415205已完成不适用
Pain and Stress Assessment and ROP Screening Examination in Premature Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Urine Stress Marker
研究概览
简要总结
The study will measure the effects of eye exams on markers of stress in the urine. In addition, measurements will be taken to show the effects of stress on brain activity, O2 sats, and blood flow.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature infants between 24 -32 weeks of gestational age
排除标准
- •Infants scheduled for laser eye surgery on the day of the examination
- •Infants with intraventricular hemorrhage ≥ grade 3 (Papile classification) diagnosed by head ultrasound
- •Infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam
- •Renal injury defined with plasma creatinine > 1.5 mg/dL
- •Severe cyanotic congenital heart disease
- •Unstable respiratory distress (hypoxemia PaO2 < 50 mm Hg or SpO2 < 90%)
结局指标
主要结局
Urine Stress Marker
时间窗: 24 hours
Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.
次要结局
- NIRS(24 hours)
- aEEG(24 hours)
研究者
Danilyn Angeles, PhD
PhD
Loma Linda University
研究点 (1)
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