Hypoxic Ischemic Encephalopathy of NewbornPhase 1NCT06522581
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
A Phase 1 study testing Citicoline Sodium in people with Hypoxic Ischemic Encephalopathy of Newborn, run by Armed Forces Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5… Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy of Newborn
- What is being tested?
- Citicoline Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Phase 1
- 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 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all indoor newborn babies with HIE II and III
- who have not received therapeutic hypothermia
Who cannot join
- grade I HIE
- Babies on TH
- babies whose parents do not give consent for inclusion in study
- babies with major congential malformations -
Trial locations and contacts
1 site in 1 country.
arshad Khushdil contact
Pakistan1 site, 1 recruiting
- Recruiting
MH
Rawalpindi, 68000
arshad Khushdil, 03463300030, drarshad104589@yahoo.com
About this study
Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.
Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.
Read the detailed description
A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.
Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.
In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.
- Being tested
- Citicoline Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline SodiumDrug
Also called placebo
one group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth
| Study group | Role | What they receive |
|---|---|---|
| neonates with HIE receiving citicoline | Experimental | this arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline Receives: Drug: Citicoline Sodium |
| neonates with HIE receiving placebo | Placebo comparator | this arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline Receives: Drug: Citicoline Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival in newborn babies with HIE
we will be evaluationg the efficacy of citicoline in newborns with HIE
Measured: one year after the 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 posted26 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic Encephalopathy of NewbornStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 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
- Investigators
- arshad Khushdil, FCPS, Principal investigator, PEMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522581
- Sponsor's protocol ID
- Citicoline for HIE
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 14 Aug 2024
- 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT06522581
- Acronym / sponsor ID
- Citicoline for HIE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Armed Forces Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.
Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.
Detailed description
A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.
Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.
In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neonates with HIE receiving citicoline | Experimental | Drug: Citicoline Sodiumthis arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline |
| neonates with HIE receiving placebo | Placebo comparator | Drug: Citicoline Sodiumthis arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- all indoor newborn babies with HIE II and III
- who have not received therapeutic hypothermia
Key exclusion criteria (4 listed)
- grade I HIE
- Babies on TH
- babies whose parents do not give consent for inclusion in study
- babies with major congential malformations -
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 |
|---|---|---|
| Citicoline SodiumAlso: placeboone group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth | Drug | neonates with HIE receiving citicoline, neonates with HIE receiving placebo |
Primary outcome
survival in newborn babies with HIE
Time frame: one year after the start of study
we will be evaluationg the efficacy of citicoline in newborns with HIE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
arshad Khushdil contact
arshad Khushdil, FCPS principal investigator
PEMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Citicoline Sodium in people with Hypoxic Ischemic Encephalopathy of Newborn, 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 4 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 14 Aug 2024. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (03463300030, drarshad104589@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival in newborn babies with HIE (time frame: one year after the start of study). 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 14 Aug 2024.