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临床试验/NCT06932354
NCT06932354已完成不适用

Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy

Kathryn Beardsall1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年5月10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
16
试验地点
1
主要终点
Percent of time glucose levels measured on CGM are in target

研究概览

简要总结

This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

详细描述

In the UK approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Hypoxic ischaemic encephalopathy Informed parental consent

排除标准

  • •Known significant congenital malformation

结局指标

主要结局

Percent of time glucose levels measured on CGM are in target

时间窗: From sensor insertion for up to the first 7 days of life

Percent Time in target (2.6-10mmol/l)

次要结局

未报告次要终点

研究者

发起方
Kathryn Beardsall
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kathryn Beardsall

Principle Investigator

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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