Role of human recombinant erythropoitein in moderate to severe hypoxic-ischemic encephalopathy in neonates a prospective comparative study

Abstract

Background Hypoxic-ischemic encephalopathy (HIE) is a significant brain injury that occurs when there is inadequate oxygen supply to the brain during the neonatal period, often resulting from perinatal asphyxia. Perinatal asphyxia leading to Hypoxic-ischemic encephalopathy (HIE) is a random event and hence early and adequate management will go a long way towards making a positive difference in the affected newborns. Hypothermia leads the management of neonatal HIE as it produces the best outcomes; morbidity and mortality rates decrease twice or even thrice when Hypothermia is applied within the first six hours after birth. The direct action of EPO is proposed to be mediated through neuroprotection, tissue repair, suppression of inflammation and maintenance of the integrity of the blood brain barrier. Our studies with rhEPO have also identified both immediate and developmental neuroprotective and reparative effects that are critical for prevention of brain damage and for post-HIE neurodevelopmental outcome. AIMS AND OBJECTIVES AIMS To Evaluate the role and effects of human recombinant erythropoietin in moderate to severe hypoxic-ischemic encephalopathy in neonates. OBJECTIVE • To assess the safety and feasibility of rhEPO in asphyxiated neonates with moderate to severe encephalopathy. • To know and to correlate the effect of EPO on EEG, RI (resistive index) in Neurosonogram (NSG), MRI brain in asphyxiated neonates with moderate to severe encephalopathy. Materials and methods It is Prospective Comparative Study conducted for a duration of 12-18 months with 92 participants. The study will include all term and near-term newborns (≥36 completed weeks) with moderate to severe hypoxic-ischemic encephalopathy (HIE), as determined by the Sarnat and Sarnat criteria. Statistical analysis: Data will be recorded in Microsoft Excel and analysed using SPSS software (Version 20). Results will be presented as Mean, SD, frequencies, percentages, and visual diagrams. Continuous Variables will be used to interpret the independent sample t test for normally distributed data and Mann-Whitney U test for non-normally distributed data. Categorical Variables: Chi-square test or Fisher’s exact test. Significance Threshold: p < 0.05 (two-tailed). Results:  In the EPO group, 47.8% (n=22) had moderate encephalopathy, while 52.2% (n=24) had severe encephalopathy. In our study we found that Amplitude–integrated electroencephalogram[aEEG] showed burst suppression [21.7% vs 6.5%], low voltage [10.9% vs 4.3%], flat trace [13.0% vs 8.7%], and status epilepticus [6.5% vs 2.2%] in control group in comparison with EPO Group.  Neurosonogram [NSG] done showed Abnormal RI [56.5% vs 15.2%] and Normal RI [43.5% vs 84.8%] in control group in comparison with EPO Group. Brain magnetic-resonance imaging [MRI] done at discharge showed severe brain injury [32.6% vs 8.6%] and regional specific HIE [19.5% vs 39.1%] in control group in comparison with EPO Group.  Mortality outcomes [10.8% vs 2.17%] in control group comparison with EPO Group. Conclusion: The research shows that it is safe and practical to provide recombinant human erythropoietin (rhEPO) to newborns with moderate to severe hypoxic-ischemic encephalopathy (HIE). In comparison to the control group, the results show that rhEPO treatment considerably lowers the occurrence of abnormal resistive index (RI). In Furthermore, EPO-treated neonates showed improvements in electroencephalographic (EEG) patterns, neuro-sonograms’ (NSG) resistive index and MRI brain findings, and suggesting possible neuroprotective advantages.