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临床试验/NCT06522581
NCT06522581招募中1 期

Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Armed Forces Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
survival in newborn babies with HIE

研究概览

简要总结

Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.

Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

详细描述

A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.

Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.

In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • all indoor newborn babies with HIE II and III
  • who have not received therapeutic hypothermia

排除标准

  • grade I HIE
  • Babies on TH
  • babies whose parents do not give consent for inclusion in study
  • babies with major congential malformations -

研究组 & 干预措施

neonates with HIE receiving citicoline

Experimental

this arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline

干预措施: Citicoline Sodium (Drug)

neonates with HIE receiving placebo

Placebo Comparator

this arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline

干预措施: Citicoline Sodium (Drug)

结局指标

主要结局

survival in newborn babies with HIE

时间窗: one year after the start of study

we will be evaluationg the efficacy of citicoline in newborns with HIE

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

Doctor

Armed Forces Hospital, Pakistan

研究点 (1)

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