Study of Citicoline to Protect the Brain in Preterm Babies Up to 1 Month Old

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 studys conclusion in December 2028.

Citicoline as Neuroprotector in Preterm