NCT03181646

Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Armed Forces Hospital, Pakistan · Academic / Other
• Sex: All
• Age: 1 Hour – 14 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
DRUG	citicoline	intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established

Timeline

• Start date: 2017-06-15
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2017-06-09
• Last updated: 2017-06-09

Locations

1 site across 1 country: Pakistan