此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

2012年10月1日 更新者:Vishal Kapadia、University of Texas Southwestern Medical Center

Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.

研究概览

研究类型

介入性

注册 (实际的)

88

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • Dallas、Texas、美国
        • Parkland Memorial Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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

  1. min 60%-65%
  2. min 65%-70%
  3. min 70%-75%
  4. min 75%-80%
  5. min 80%-85%

10 min 85%-94%

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%

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
Reduction in mean oxidative balance ratio at 1 hour of life
大体时间:Cord blood and at 1 hour of life
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.
Cord blood and at 1 hour of life

次要结果测量

结果测量
大体时间
Total oxygen load used during active resuscitation
大体时间:First 10 minutes of life
First 10 minutes of life
Saturations achieved during first 10 minutes of life
大体时间:First 10 minutes of life
First 10 minutes of life
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
First 10 minutes of life
Time spent with saturation above 94% during active resuscitation
大体时间:First 10 minutes of life
First 10 minutes of life
Need for respiratory support in the delivery room
大体时间:First 10 minutes of life
First 10 minutes of life
支气管肺发育不良
大体时间:孕后 36 周
孕后 36 周
Length of hospitalization
大体时间:From date of randomization to date of discharge, expected average of 8 weeks
From date of randomization to date of discharge, expected average of 8 weeks
Retinopathy of Prematurity
大体时间:40 weeks postconceptional age
40 weeks postconceptional age
新生儿死亡率
大体时间:28天的生命
28天的生命
Death before discharge
大体时间:From date of randomization to date of discharge, expected average of 8 weeks
From date of randomization to date of discharge, expected average of 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2011年1月1日

研究完成 (实际的)

2011年1月1日

研究注册日期

首次提交

2012年9月25日

首先提交符合 QC 标准的

2012年10月1日

首次发布 (估计)

2012年10月2日

研究记录更新

最后更新发布 (估计)

2012年10月2日

上次提交的符合 QC 标准的更新

2012年10月1日

最后验证

2012年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • STU 052011-044

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅