Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2017-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoxic-Ischemic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

study group

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

Group Type EXPERIMENTAL

citicoline

Intervention Type DRUG

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

Interventions

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citicoline

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

1 Hour

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No