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临床试验/NCT01697904
NCT01697904已完成不适用

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

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Reduction in mean oxidative balance ratio at 1 hour of life

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Gestation age 24 0/7 to 34 6/7
  • Need for active resuscitation

排除标准

  • Prenatally diagnosed cyanotic congenital heart disease
  • Non-viable newborns
  • Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation

结局指标

主要结局

Reduction in mean oxidative balance ratio at 1 hour of life

时间窗: 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.

次要结局

  • Total oxygen load used during active resuscitation(First 10 minutes of life)
  • Saturations achieved during 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(First 10 minutes of life)
  • Time spent with saturation above 94% during active resuscitation(First 10 minutes of life)
  • Need for respiratory support in the delivery room(First 10 minutes of life)
  • Bronchopulmonary dysplasia(36 weeks postconceptional age)
  • Length of hospitalization(From date of randomization to date of discharge, expected average of 8 weeks)
  • Retinopathy of Prematurity(40 weeks postconceptional age)
  • Neonatal mortality(28 days of life)
  • Death before discharge(From date of randomization to date of discharge, expected average of 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vishal Kapadia

Assistant Professor of Pediatrics

University of Texas Southwestern Medical Center

研究点 (1)

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