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临床试验/NCT02804555
NCT02804555已完成不适用

Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section

Szeged University2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
2
主要终点
Hyperoxia Newborns

研究概览

简要总结

In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.

详细描述

Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Elective cesarean section.
  • Signed informed consent form.

排除标准

  • Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.

结局指标

主要结局

Hyperoxia Newborns

时间窗: through study completion up to two years

We measured umbilical vein blood gas parameters.

次要结局

  • Maternal hyperoxia(through study completion up to two years)
  • Alterations in newborns' enzyme functions due to maternal hyperoxia(through study completion up to two years)

研究者

发起方
Szeged University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Domonkos Trásy

clinician

Szeged University

研究点 (2)

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