Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-30
SponsorArmed Forces Hospital, Pakistan

About this trial

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

Qualifiers

all indoor newborn babies with HIE II and III

who have not received therapeutic hypothermia

Disqualifiers

grade I HIE

Babies on TH

babies whose parents do not give consent for inclusion in study

babies with major congential malformations -

Trial design

Treatments tested in this trial

  • Citicoline Sodium

Treatment groups

200 Participants
are divided into 2 treatment groups