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Background. Hypoxic-ischemic encephalopathy (HIE) remains one of the leading causes of morbidity and disability among term newborns. Therapeutic hypothermia (TH) is the standard of care in high-income countries; however, data on the effectiveness of different cooling methods (use of servo-controlled cooling equipment versus non-device hypothermia) in low- and middle-income settings remain limited. The associations between the frequency of acute intranatal events and the development of adverse HIE outcomes constitute another subject of discussion. The purpose of this retrospective observational study was to determine the clinical equivalence of device-based and non-device systemic therapeutic hypothermia in term newborns with hypoxic-ischemic encephalopathy by comparing the incidence of short-term adverse outcomes (primary endpoint) and individual clinical indicators of the neonatal period (secondary endpoints). Materials and methods. A retrospective analysis of medical records was performed in 117 term newborns with severe birth asphyxia who underwent systemic TH: 98 infants received non-device therapeutic hypothermia (NDTH), and 19 received device-based therapeutic hypothermia (DTH). Anamnestic features of the perinatal period and clinical characteristics of the neonatal period were assessed. The severity of multi-organ dysfunction was determined using the MODE scale. Short-term adverse outcomes included destructive hypoxic-ischemic brain injury, seizures, abnormal muscle tone, and the absence of full oral feeding at discharge. Statistical processing was performed using the Mann-Whitney test and Fisher’s exact test, multivariate logistic regression analysis. Results. The groups did not differ in gestational age, birth weight, Apgar scores at 1 and 10 minutes, or pH level during the first hour of life. In the NDTH group, significantly longer sedation, longer time to recovery of consciousness and muscle tone, later initiation of enteral feeding, and a longer stay in the intensive care unit were observed. At the same time, no statistically significant differences were found between the groups in seizure frequency, MODE scores, or the incidence of short-term adverse HIE outcomes. Differences in the clinical course (newborns who received NDTH had significant differences compared to the DTH group, namely lower Apgar score at 5 minute, longer sedation and longer time to recovery of consciousness and muscle tone, to initiation of enteral feeding) could be attributable to changes in recommendations regarding sedation practices, choice of medications, and initiation of enteral feeding during TH. Destructive hypoxic-ischemic brain tissue injury was observed in 20.5 % of children in the overall cohort. Despite the presence of certain clinical differences during neonatal period, no statistically significant difference in the frequency of short-term adverse outcomes was detected between groups with different cooling methods (however, the presence of a clinically important difference cannot be excluded due to limited statistical power). An increase in the frequency of short-term adverse HIE outcomes in children after DTH compared to the NDTH group (26.3 versus 19.4 %) was accompanied by a decrease in the frequency of intranatal risk factors in the DTH group (15.8 versus 33.7 %); however, these differences were not statistically significant. Conclusions. In this retrospective study with a limited number of newborn patients with hypoxic-ischemic encephalopathy who received device-based therapeutic hypothermia, no statistically significant difference was found in the frequency of short-term adverse outcomes in the NDTH group compared to the DTH group. However, due to the small sample size of the device-based therapeutic hypothermia group and the possible influence of changes in care protocols, the conclusions are preliminary and require confirmation in larger prospective studies. The decisive factors for the effectiveness of TH remain the timeliness of its application and adherence to standards, adequate temperature control, and comprehensive intensive management.