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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Citicoline Sodium
Drugone group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: neonates with HIE receiving citicolineExperimental treatment 1 intervention
Group B: neonates with HIE receiving placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
survival in newborn babies with HIE
we will be evaluationg the efficacy of citicoline in newborns with HIE
Time frame
one year after the start of studySponsors and contacts
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Source ClinicalTrials.gov