Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Hypoxic-Ischemic Encephalopathy Clinical Trial

— citicoline  

Official title:

Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03181646
• Other study ID #: CITICOLINE
• Status: Recruiting
• Phase: Phase 3
• First received: June 5, 2017
• Last updated: June 7, 2017
• Start date: June 15, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: June 2017
• Source: Armed Forces Hospital, Pakistan
• Contact: arshad khushdil, FCPS
• Phone: 03463300030
• Email: drarshad104589[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• • Newborn babies having grade 2 and 3 HIE, of both genders delivered in labor room or operation theatre of our hospital.

• Outdoor patients presenting within 24 hours of delivery

Exclusion Criteria:

• • Outborn babies presenting after 24 hours of delivery.

• Patients with severe congenital malformations

• Babies born extremely prematurely (less than 28 weeks)

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

Drug:
• citicoline
intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established

Locations

Country	Name	City	State
Pakistan	Department of Pediatrics	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on sucking	time to establish full oral feeds	06 months after start of study
Primary	discharge time	time to discharge from hospital	06 months after start of study
Primary	effect on seizures	duration of seizures	06 months after start of study