NCT06522581

Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Armed Forces Hospital, Pakistan · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Hypoxic Ischemic Encephalopathy of Newborn

Interventions

Type	Name	Description
DRUG	Citicoline Sodium	one group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-07-26
• Last updated: 2024-08-14

Locations

1 site across 1 country: Pakistan