Using Citicoline to protect the brains of newborns with low oxygen levels
Efficacy of Citicoline as Neuroprotector in Neonates Exposed to Hypoxia: A Randomized Controlled Trial
PHASE3 · Tanta University · NCT03949049
This study is testing if Citicoline can help protect the brains of newborns who didn't get enough oxygen at birth.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 1 Month |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT03949049 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Citicoline as a neuroprotective agent in neonates who have experienced hypoxia. It is a randomized controlled trial where participants will receive either Citicoline or a placebo to assess the drug's impact on brain health. The study aims to determine if Citicoline can mitigate potential neurological damage caused by low oxygen levels during birth. The trial is designed to provide robust data on the safety and efficacy of this intervention in a vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates who have experienced hypoxia but do not have hypoxic ischemic encephalopathy.
Not a fit: Patients with hypoxic ischemic encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve neurological outcomes for newborns affected by hypoxia.
How similar studies have performed: Other studies have explored neuroprotective strategies in neonates, but the specific use of Citicoline in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * neonates with hypoxia. Exclusion Criteria: * hypoxic ischemic encephalopathy
Where this trial is running
Cairo
- Sherief Abd-Elsalam — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Abeer Salamah, Lecturer — Pediatrics department - Kafr-Elsheikh university
- Study coordinator: sherief abd-elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
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.
Conditions: Neonatal Hypoxia