Hypoxic-Ischemic EncephalopathyPhase 3citicolineNCT03181646
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
A Phase 3 study testing citicoline in people with Hypoxic-Ischemic Encephalopathy, run by Armed Forces Hospital, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 14 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- citicoline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2017to 15 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- • Outborn babies presenting after 24 hours of delivery.
- Patients with severe congenital malformations
- Babies born extremely prematurely (less than 28 weeks)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Pediatrics
Rawalpindi, Punjab Province, 68000
arshad khushdil, FCPS, 03463300030, drarshad104589@yahoo.com
About this study
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.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- citicoline
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citicolineDrug
intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: citicoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on sucking
time to establish full oral feeds
Measured: 06 months after start of study
discharge time
time to discharge from hospital
Measured: 06 months after start of study
effect on seizures
duration of seizures
Measured: 06 months after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion15 Dec 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, arshad khushdil, Armed Forces Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181646
- Sponsor's protocol ID
- CITICOLINE
- Acronym
- citicoline
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT03181646
- Acronym / sponsor ID
- citicoline / CITICOLINE
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Armed Forces Hospital, PakistanUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 15 Dec 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –newborns with hypoxic ischemic encephalopathy grade 2/3 who will receive only supportive care |
| study group | Experimental | Drug: citicolinenewborns with hypoxic ischemic encephalopathy grade 2/3 who will receive citicoline along with supportive care |
Who may qualify
- Ages
- 1 hour to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • Newborn babies having grade 2 and 3 HIE, of both genders delivered in labor room or operation theatre of our hospital.
Key exclusion criteria (3 listed)
- • Outborn babies presenting after 24 hours of delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citicolineintravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established | Drug | study group |
Primary outcome
effect on sucking
Time frame: 06 months after start of study
time to establish full oral feeds
discharge time
Time frame: 06 months after start of study
time to discharge from hospital
effect on seizures
Time frame: 06 months after start of study
duration of seizures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Related trials for Hypoxic-Ischemic Encephalopathy
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing citicoline in people with Hypoxic-Ischemic Encephalopathy, run by Armed Forces Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact arshad khushdil, FCPS (03463300030, drarshad104589@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on sucking (time frame: 06 months after start of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.