Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy (citicoline)
Primary Purpose
Hypoxic-Ischemic Encephalopathy
Status
Unknown status
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
citicoline
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy
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)
Sites / Locations
- Department of PediatricsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
study group
Arm Description
newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive only supportive care
newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive citicoline along with supportive care
Outcomes
Primary Outcome Measures
effect on sucking
time to establish full oral feeds
discharge time
time to discharge from hospital
effect on seizures
duration of seizures
Secondary Outcome Measures
Full Information
NCT ID
NCT03181646
First Posted
June 5, 2017
Last Updated
June 7, 2017
Sponsor
Armed Forces Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT03181646
Brief Title
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Acronym
citicoline
Official Title
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Anticipated)
Primary Completion Date
December 15, 2017 (Anticipated)
Study Completion Date
December 15, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Hospital, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive only supportive care
Arm Title
study group
Arm Type
Experimental
Arm Description
newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive citicoline along with supportive care
Intervention Type
Drug
Intervention Name(s)
citicoline
Intervention Description
intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established
Primary Outcome Measure Information:
Title
effect on sucking
Description
time to establish full oral feeds
Time Frame
06 months after start of study
Title
discharge time
Description
time to discharge from hospital
Time Frame
06 months after start of study
Title
effect on seizures
Description
duration of seizures
Time Frame
06 months after start of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
arshad khushdil, FCPS
Phone
03463300030
Email
drarshad104589@yahoo.com
Facility Information:
Facility Name
Department of Pediatrics
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
68000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
arshad khushdil, FCPS
Phone
03463300030
Email
drarshad104589@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
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