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OPTIMIZING NEONATAL HYPOGLYCEMIA MANAGEMENT: A PILOT RANDOMIZED CONTROLLED TRIAL OF A NOVEL PROTOCOL FOR INTRAVENOUS FLUIDS IN THE NICU
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The purpose of the study. Compared to Neonates with hypoglycemia should be treated according to the standard protocol, a new protocol is evaluated for safety. Methods. A pilot RCT with an open label. We included neonates who required intravenous fluids due to hypoglycemia during their stay in the NICU. An intervention group of 114 eligible neonates (glycemic control increased by 1.5%) and a standard protocol group (gastric emptying rate increased by 2 mg/kg/min) were randomly assigned. The primary aim of the study was to determine the Following enrollment in the study, the percentage of infants who developed hypoglycemia and hyperglycemia. Results. The initial GIR (6 ± 0?mg/kg/min versus 4.8 ± 1.4?mg/kg/min, P < 0.001), the mean maximum GIR (6.7 ± 1.6?mg/kg/min versus 5.6 ± 2?mg/kg/min, P = 0.03), the maximum concentration of glucose infused (13.8 ± 2.9% versus 10.9 ± 1.9%, P < 0.001), and the total amount of glucose infused in the intervention group, were significantly lower. Compared to the conventional protocol group where there were only five infants with hyperglycemia There was a significant difference between groups (n = 20, 39% versus n = 10, 16%, P = 0.07) in the mean maximum blood sugar levels (129x57 mg/dL versus 87x30 mg/dL, P = 0.001). When the highest and lowest recorded sugar concentrations were compared in the standard protocol group (median 93 mg/dL, IQR 52 to 147 mg/dL versus median 50 mg/dL, IQR 38 to 62.5 mg/dL, P = 0.03), significant differences were observed. Conclusion. Hypoglycemia in neonates can be managed effectively with a new and innovative algorithm, but this needs to be tested further before it is practiced routinelyddd