drugset / Trial / NCT06522581

Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

NCT06522581

Phase 1 Recruiting 200 enrolled Armed Forces Hospital, Pakistan
RandomizedParallel-groupTriple-blindTreatment

Summary

Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births. Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

Timeline

Start
2024-01-01
Primary completion
2025-01-01
Completion
2025-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Citicoline Other / unclassified Intravenous