Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国
- Parkland Memorial Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Inborn
- Gestation age 24 0/7 to 34 6/7
- Need for active resuscitation
Exclusion Criteria:
- Prenatally diagnosed cyanotic congenital heart disease
- Non-viable newborns
- Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Low Oxygen Strategy
Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR < 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized. Targeted Pre-ductal SpO2 After birth
10 min 85%-94% |
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有源比较器:Traditional Oxygen strategy ( TOX)
Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94%
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reduction in mean oxidative balance ratio at 1 hour of life
大体时间:Cord blood and at 1 hour of life
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Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants.
Oxidative balance ratio was calculated from this formula.
Oxidative balance ratio = BAP/TH.
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Cord blood and at 1 hour of life
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Total oxygen load used during active resuscitation
大体时间:First 10 minutes of life
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First 10 minutes of life
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Saturations achieved during first 10 minutes of life
大体时间:First 10 minutes of life
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First 10 minutes of life
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Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
大体时间:First 10 minutes of life
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First 10 minutes of life
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Time spent with saturation above 94% during active resuscitation
大体时间:First 10 minutes of life
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First 10 minutes of life
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Need for respiratory support in the delivery room
大体时间:First 10 minutes of life
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First 10 minutes of life
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支气管肺发育不良
大体时间:孕后 36 周
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孕后 36 周
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Length of hospitalization
大体时间:From date of randomization to date of discharge, expected average of 8 weeks
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From date of randomization to date of discharge, expected average of 8 weeks
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Retinopathy of Prematurity
大体时间:40 weeks postconceptional age
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40 weeks postconceptional age
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新生儿死亡率
大体时间:28天的生命
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28天的生命
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Death before discharge
大体时间:From date of randomization to date of discharge, expected average of 8 weeks
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From date of randomization to date of discharge, expected average of 8 weeks
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合作者和调查者
调查人员
- 首席研究员:Vishal S Kapadia, MD、Ut Southwestern
- 首席研究员:Myra H Wyckoff, MD、Ut Southwestern
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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