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临床试验/NCT03181646
NCT03181646Unknown3 期

Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Armed Forces Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
50
试验地点
1
主要终点
effect on sucking

研究概览

简要总结

Citicoline, is a naturally occurring compound and an intermediate in the metabolism of phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of the cell membranes. Citicoline is composed of two molecules: cyti¬dine and choline. Both these molecules enter the brain separately and by passing through the blood-brain barrier where they act as substrates for intracellular synthesis of CDP-choline . This drug has been widely used in adults who suffer from acute ischemic strokes for than 4 decades with good results and has been proved to have a very good safety profile as well. It has various therapeutic effects at several stages of the ischemic cascade in acute ischemic stroke.

  1. It stabilizes cell membranes by increasing phosphatidylcholine and sphingomyelin synthesis and by inhibiting the release of free fatty acids . By protecting membranes, citicoline inhibits glutamate release during ischemia. In an experimental model of ischemia in the rat, citicoline treatment decreased glutamate levels and stroke size.
  2. Citicoline favors the synthesis of nucleic acids, proteins, acetylcholine and other neurotransmitters, and decreases free radical formation Therefore, citicoline simultaneously inhibits different steps of the ischemic cascade protecting the injured tissue against early and delayed mechanisms responsible for ischemic brain injury.
  3. citicoline may facilitate recovery by enhancing synaptic outgrowth and increased neuroplasticity with decrease of neurologic deficits and improvement of behavioral performance.

Considering these pharmacologic properties of citicoline, we are planning to see its effects in newborns who have HIE which causes a global acute ischemic changes in developing brain.

研究设计

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

入排标准

年龄范围
1 Hour 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • • Newborn babies having grade 2 and 3 HIE, of both genders delivered in labor room or operation theatre of our hospital.
  • Outdoor patients presenting within 24 hours of delivery

排除标准

  • • Outborn babies presenting after 24 hours of delivery.
  • Patients with severe congenital malformations
  • Babies born extremely prematurely (less than 28 weeks)

研究组 & 干预措施

study group

Experimental

newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive citicoline along with supportive care

干预措施: citicoline (Drug)

结局指标

主要结局

effect on sucking

时间窗: 06 months after start of study

time to establish full oral feeds

discharge time

时间窗: 06 months after start of study

time to discharge from hospital

effect on seizures

时间窗: 06 months after start of study

duration of seizures

次要结局

未报告次要终点

研究者

发起方
Armed Forces Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

arshad khushdil

Fellow Neonatology Department

Armed Forces Hospital, Pakistan

研究点 (1)

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