Citicoline in hypoxic ischemic encephalopathy in neonates: a randomized controlled trial

Area of Science:

• Neonatal Neurology
• Neuroprotection
• Clinical Trials

Background:

• Hypoxic-ischemic encephalopathy (HIE) is a critical condition in neonates, often leading to severe disability or death.
• Therapeutic cooling is a standard treatment, but not all neonates are candidates.
• Investigating novel neuroprotective agents for HIE is crucial.

Purpose of the Study:

• To evaluate the efficacy of citicoline as a neuroprotective agent in neonates with moderate to severe HIE.
• To assess the impact of citicoline on clinical outcomes and neuroimaging in this vulnerable population.

Main Methods:

• A randomized clinical trial involving 80 neonates with moderate to severe HIE ineligible for therapeutic cooling.
• Participants were assigned to receive either citicoline (10 mg/kg/12h IV for 4 weeks) or a placebo, alongside supportive care.
• Outcomes measured included duration of mechanical ventilation, inotrope use, seizure characteristics, NICU stay, cranial ultrasound, MRI, and neurodevelopmental assessments up to 12 months.

Main Results:

• Citicoline significantly reduced post-discharge seizures (2 vs. 11 neonates).
• Improved cranial ultrasound and MRI findings were observed at 4 weeks in the citicoline group.
• Significant improvements in neurodevelopmental outcomes at 9 and 12 months, alongside reduced NICU stay, inotrope use, and mechanical ventilation duration.

Conclusions:

• Citicoline shows promise as an effective neuroprotective drug for neonates suffering from HIE.
• The treatment was well-tolerated with no significant adverse effects reported.
• Further research may support citicoline's role in managing neonatal HIE.