Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
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
- 否
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
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
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
arshad khushdil
Doctor
Armed Forces Hospital, Pakistan
