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临床试验/NCT04802629
NCT04802629已完成不适用

Influence of Fetal Haemoglobin on Cerebral and Peripheral Oxygenation in Term and Preterm Neonates During the First Two Weeks After Birth Measured by Near Infrared Spectroscopy- a Prospective Observational Pilot Study

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月8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
50
试验地点
1
主要终点
HbF (g/dL)

研究概览

简要总结

The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS (near-infrared spectroscopy ), and the FHbF (fraction of fetal hemoglobin) and absolute HbF (fetal hemoglobin) concentration in postnatal conditions in term and preterm neonates.

详细描述

During gestation the main fetal oxygen carrier is fetal hemoglobin (HbF). HbF exhibits a significantly higher affinity for oxygen when compared to adult hemoglobin (HbA), which makes it more suitable for oxygen extraction at the lower partial oxygen pressures in utero. Although the regulation of HbF expression is determined developmentally, recent studies report a respectable variation in the fraction of HbF in neonates.

Such data suggest that the differences in HbF expression could affect end-tissue oxygenation in neonates.

The methodology for measuring oxygen saturation and extraction in cerebral and peripheral tissues of neonates using the near-infrared spectroscopy (NIRS) has been well practiced in our study group. However, the method has not yet been used to investigate whether the fraction of fetal hemoglobin (FHbF) plays a significant role in cerebral and peripheral oxygenation in neonates.

The aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by NIRS, and the FHbF and absolute HbF concentration in postnatal conditions in term and preterm neonates.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
2 Days 至 3 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Term and preterm neonates admitted to the neonatal intensive care unit (NICU)
  • Decision to conduct full life support
  • Written informed consent

排除标准

  • No decision to conduct full life support
  • No written informed consent
  • Congenital malformations
  • Family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)

结局指标

主要结局

HbF (g/dL)

时间窗: First two weeks after birth

Fetal hemoglobin concentration in g/dL

Change of cFTOE

时间窗: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

cerebral fractional tissue oxygen extraction (cFTOE)

FHbF (%)

时间窗: First two weeks after birth

Fraction of fetal hemoglobin in percentage

Change of cTOI

时间窗: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

cerebral tissue oxygenation index (cTOI)

Change of pTOI

时间窗: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

peripheral tissue oxygenation index (pTOI)

Change of pFTOE

时间窗: at specific time points (2nd-3rd 6th-8th, 12th-14th day after birth)

peripheral fractional tissue oxygen extraction (pFTOE)

次要结局

未报告次要终点

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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