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

June 7, 2017 updated by: arshad khushdil, Armed Forces Hospital, Pakistan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 68000
        • Recruiting
        • Department of Pediatrics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive only supportive care
Experimental: study group
newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive citicoline along with supportive care
Drug: citicoline
intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on sucking
Time Frame: 06 months after start of study
time to establish full oral feeds
06 months after start of study
discharge time
Time Frame: 06 months after start of study
time to discharge from hospital
06 months after start of study
effect on seizures
Time Frame: 06 months after start of study
duration of seizures
06 months after start of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2017

Primary Completion (Anticipated)

December 15, 2017

Study Completion (Anticipated)

December 15, 2017

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Citicoline

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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