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Recruiting Phase 1 NCT06522581

Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Trial Parameters

Condition Hypoxic Ischemic Encephalopathy of Newborn
Sponsor Armed Forces Hospital, Pakistan
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 200
Sex ALL
Min Age 1 Day
Max Age 30 Days
Start Date 2024-01-01
Completion 2025-01-01
Interventions
Citicoline Sodium

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. all indoor newborn babies with HIE II and III 2. who have not received therapeutic hypothermia Exclusion Criteria: 1. grade I HIE 2. Babies on TH 3. babies whose parents do not give consent for inclusion in study 4. babies with major congential malformations -

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