A Phase 1 interventional study of Citicoline Sodium in Hypoxic Ischemic Encephalopathy of Newborn, sponsored by Armed Forces Hospital, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Armed Forces Hospital, Pakistan · Phase 1, Interventional, and Treatment
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.
A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.
Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.
In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Armed Forces Hospital, Pakistan is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
this arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline
Drug: Citicoline Sodium
this arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline
Drug: Citicoline Sodium
one group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth
Also known as: placebo
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 study
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
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Armed Forces Hospital, Pakistan