Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy (citicoline)

Armed Forces Hospital, Pakistan

Status and phase: Unknown; Phase 3

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Drug: citicoline

Study type: Interventional

Funder types: Other

Identifiers

NCT03181646

CITICOLINE

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 hour to 14 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control group

No Intervention group

Description:

newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive only supportive care

study group

Experimental group

Description:

newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive citicoline along with supportive care

Treatment:

Drug: citicoline