Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

NCT03181646 | Unknown Phase 3

• 1 other identifier: CITICOLINE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.citicoline may facilitate recovery by enhancing synaptic outgrowth and increased neuroplasticity with decrease of neurologic deficits and improvement of behavioral performance.

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (3)

• effect on sucking

  time to establish full oral feeds

  06 months after start of study

• discharge time

  time to discharge from hospital

  06 months after start of study

• effect on seizures

  duration of seizures

  06 months after start of study

Study Arms (2)

control group

NO INTERVENTION

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

study group

EXPERIMENTAL

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

Drug: citicoline

Interventions

citicoline DRUG

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

study group

Eligibility Criteria

• Age: 1 Hour - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Outborn babies presenting after 24 hours of delivery.
• Patients with severe congenital malformations
• Babies born extremely prematurely (less than 28 weeks)

Sponsors & Collaborators

• Armed Forces Hospital, Pakistan: lead

Study Sites (1)

Department of Pediatrics

Rawalpindi, Punjab Province, 68000, Pakistan

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

arshad khushdil, FCPS

CONTACT

03463300030; drarshad104589@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Neonatology Department

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: June 15, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Locations

PA (1)