An interventional study of Citicoline and Standard medical treatment in Hypoxic Ischaemic Encephalopathy (HIE), sponsored by Khyber Girls Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 0 Hours to 24 Hours. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Khyber Girls Medical College · Not applicable, Interventional, and Treatment
To determine the efficacy of citicoline in improving cerebral blood flow parameters and neurological status among neonates with hypoxic-ischemic encephalopathy using Doppler resistive index and Sarnat-Sarnat score after 72 hours of therapy.
Hypoxic-ischemic encephalopathy (HIE) is a leading cause of neonatal brain injury worldwide. In the developed world, the incidence is estimated at up to 8 per 1,000 live births, while in developing countries, estimates are as high as 26 per 1,000 live births. Approximately 20-30% of infants with HIE die in the neonatal period, and 33-50% of survivors are left with permanent neurodevelopmental abnormalities.1 HIE can be classified into mild (Stage I), moderate (Stage II), and severe (Stage III) based on the Sarnat and Sarnat staging system(Table 1), with stage II and III being associated with the highest morbidity and mortality.
Therapeutic hypothermia remains the standard therapy for HIE. However, its availability, high costs, need for specialized equipment and monitoring limit its use in developing countries like Pakistan, therefore alternative neuroprotective agents are used however there is still no consensus regarding which agent is the most effective. Citicoline (cytidine diphosphate choline) has demonstrated several neuroprotective mechanisms. It helps preserve neuronal membrane integrity by maintaining phospholipids while decreasing phospholipase A2 activity and oxidative damage.2 It also enhances phosphatidylcholine synthesis and promotes glutathione production, thereby decreasing free-radical-mediated neuronal injury. Experimental studies further suggest neuroprotective roles of citicoline as it modulates excitotoxicity by decreasing glutamate levels.3,4 These combined effects may contribute to improved neuronal survival and recovery after hypoxic-ischemic insults. Long term effects have been studied however no study evaluates short term improvement from therapy.
Resistive Index is a parameter assessed on cranial doppler ultrasonography, it is difference between peak systolic and end diastolic pressures in the anterior cerebral arteries, normal value is 0.68-0.72 5it demonstrates cerebral blood flow changes due to hypoxia, lower values have been associated with worse neurological outcome.5 RI has been studied in comparison to MRI and also its changes pre and post therapeutic hypothermia, and has been found to be useful tool6,7. American Academy of Neurology and Practice Committee of the Child Neurology Society recommends RI and end diastolic flow velocity (EDFV) in the anterior cerebral artery to assess cerebral perfusion and early prediction of outcome.8 This study is therefore designed to assess the effect of citicoline on cerebral resistive index and neurological improvement using Sarnat-Sarnat scoring after 3 days of treatment in neonates with hypoxic-ischemic encephalopathy. The findings may contribute to establishing evidence for adjunctive therapeutic strategies aimed at reducing neurological morbidity in affected neonates. Despite its clinical use in some centers, there is limited published evidence regarding the efficacy of citicoline in neonates with HIE.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's planned enrollment of 86 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Khyber Girls Medical College is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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EXCLUSION CRITERIA :
This will receive medicine citicoline with standard care
Drug: Citicoline
Only receive standard care
Other: Standard medical treatment
This group will receive drug and standard care
This group will receive only standard care
Sarnat and Sarnat scoring
Time frame: enrollment to 72 hours
Cerebral Resistive Index
Time frame: Enrollment to 72 hours
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cytidine Diphosphate Choline
Khyber Girls Medical College