Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522581
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 15 per 1000 live births while developing nations experience a wider range from 23 to 265 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None