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Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03181646
Acronym
citicoline
Enrollment
50
Registered
2017-06-09
Start date
2017-06-15
Completion date
2017-12-15
Last updated
2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic-Ischemic Encephalopathy

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. 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.

Interventions

DRUGciticoline

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

Sponsors

Armed Forces Hospital, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 14 Days
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
effect on sucking06 months after start of studytime to establish full oral feeds
discharge time06 months after start of studytime to discharge from hospital
effect on seizures06 months after start of studyduration of seizures

Countries

Pakistan

Contacts

Primary Contactarshad khushdil, FCPS
drarshad104589@yahoo.com03463300030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026