Role of Citicoline in Treatment of Newborns With Hypoxic... | NCT03181646

Studies
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

NCT03181646

Sponsor

Armed Forces Hospital, Pakistan

Status

Unknown status

Last Update Posted

Jun 9, 2017Actual

Enrollment

50Estimated

Phase

Phase 3

Conditions

Hypoxic-Ischemic Encephalopathy

Interventions

citicoline

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Estimated

Primary Completion Date

Dec 15, 2017Estimated

Completion Date

Dec 15, 2017Estimated

First Submitted Date

Jun 5, 2017

First Submission Date that Met QC Criteria

Jun 7, 2017

First Posted Date

Jun 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2017

Last Update Posted Date

Jun 9, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

arshad khushdil, Fellow Neonatology Department, Armed Forces Hospital, PakistanPrincipal Investigator

Lead Sponsor

Armed Forces Hospital, PakistanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.
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.
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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
citicoline	Drug	intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

14 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
arshad khushdil, FCPS	Contact	03463300030		drarshad104589@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics	Recruiting	Rawalpindi	Punjab Province	68000	Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D020925	Hypoxia-Ischemia, Brain

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003566	Cytidine Diphosphate Choline

Ancestor Terms

ID	Term
D002794	Choline
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines

Browse Leaves

Not provided

Browse Branches

Not provided