Using Citicoline to Treat Newborns with Brain Injury from Asphyxia
Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
This study is testing if citicoline can help newborns with brain injuries from lack of oxygen due to asphyxia feel better and recover more effectively.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Day to 30 Days |
| Sex | All |
| Sponsor | Armed Forces Hospital, Pakistan Academic / other |
| Locations | 1 site (Rawalpindi) |
| Trial ID | NCT06522581 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of citicoline, a neuroprotective agent, in treating neonates suffering from moderate to severe hypoxic ischemic encephalopathy (HIE) due to asphyxia. Given the limitations of current treatments like therapeutic hypothermia, which cannot be applied in all cases, this trial aims to explore citicoline's potential to regenerate neuronal cells and improve outcomes in affected infants. The study will include newborns who have not undergone therapeutic hypothermia and will assess the safety and efficacy of citicoline in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns diagnosed with moderate to severe hypoxic ischemic encephalopathy who have not received therapeutic hypothermia.
Not a fit: Patients with grade I HIE or those who have already undergone therapeutic hypothermia will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and long-term disabilities in newborns with hypoxic ischemic encephalopathy.
How similar studies have performed: While citicoline has shown promise in other neurological conditions, its application in treating hypoxic ischemic encephalopathy in neonates is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. all indoor newborn babies with HIE II and III 2. who have not received therapeutic hypothermia Exclusion Criteria: 1. grade I HIE 2. Babies on TH 3. babies whose parents do not give consent for inclusion in study 4. babies with major congential malformations -
Where this trial is running
Rawalpindi
- Mh — Rawalpindi, Pakistan (Recruiting)
Study contacts
- Principal investigator: arshad Khushdil, FCPS — Pemh
- Study coordinator: arshad Khushdil
- Email: drarshad104589@yahoo.com
- Phone: 03463300030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.