Actively Recruiting
Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
Led by Sherief Abd-Elsalam · Updated on 2019-05-29
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the use of Citicoline as a neuroprotective agent in preterm infants. The study is a randomized controlled trial aiming to evaluate the effectiveness of Citicoline in protecting the brains of these very young patients. It is a Phase 3 trial focused on improving neurological outcomes in preterm babies. Participants are randomly assigned to receive either Citicoline or a placebo oral tablet. The study includes a blinded design where neither the participants, caregivers, investigators, nor outcome assessors know which treatment is given. This setup is designed to fairly compare the effects of Citicoline against no active drug. During the study, researchers monitor the infants for brain affection at 6 months as the primary outcome measure. The trial involves careful medical assessments and follow-up to evaluate brain health. Participation includes receiving the assigned treatment and undergoing evaluations to track any neurological impact over time until the study's conclusion in December 2028.
CONDITIONS
Brief Title
Citicoline as Neuroprotector in Preterm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infant on CPAP or ventilator
You will not qualify if you...
- Multiple congenital anomalies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive either Citicoline or a placebo as neuroprotective treatment.
Trial Site Locations
Total: 1 location
1
Sherief Abd-Elsalam
Tanta, Egypt
Actively Recruiting
Research Team
S
Sherief Abd-Elsalam, ass. prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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